Angiodynamics, Inc.
Medical device manufacturer in Marlborough, MA.
90510(k) clearances
0PMA approvals
135recalls
Device types
- GEX Powered Laser Surgical Instrument 16
- DQO Catheter, Intravascular, Diagnostic 11
- LJS Catheter, Intravascular, Therapeutic… 10
- QEY Mechanical Thrombolysis Catheter 6
- NEY System, Ablation, Microwave And Accessories 5
- OAB Low Energy Direct Current Thermal Ablation… 5
- FGE Stents, Drains And Dilators For The Biliary… 5
- QEZ Aspiration Thrombectomy Catheter 4
- DWF Catheter, Cannula And Tubing, Vascular… 4
- MSD Catheter, Hemodialysis, Implanted 4
- DYB Introducer, Catheter 4
- DQY Catheter, Percutaneous 3
- LJT Port & Catheter, Implanted, Subcutaneous… 3
- FPA Set, Administration, Intravascular 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
- LIT Catheter, Angioplasty, Peripheral… 1
- DQR Cannula, Catheter 1
- DXE Catheter, Embolectomy 1
- FRN Pump, Infusion 1
- DWE Tubing, Pump, Cardiopulmonary Bypass 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253198 | NanoKnife Generator (H78720300351US0)OAB · Traditional | 03/24/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | 11/24/2025SE |
| K253106 | AngioVac CannulaDWF · Special | 10/24/2025SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
| K212386 | AngioVac F18 85DWF · Traditional | 09/30/2021SE |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemQEZ · Traditional | 06/04/2021SE |
| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | 09/15/2020SE |
| K192864 | UNI*FUSE Infusion System with Cooper WireQEY · Traditional | 06/01/2020SE |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT · Traditional | 05/22/2020SE |
| K190594 | AngioVac C20, AngioVac C180DWF · Traditional | 07/05/2019SE |
| K183385 | NanoKnife SystemOAB · Traditional | 06/18/2019SE |
| K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm)…NEY · Traditional | 02/28/2019SE |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersDQO · Special | 07/18/2018SE |
| K181044 | 400um Perforator and Accessory Vein Ablation KitGEX · Traditional | 07/05/2018SE |
| K171921 | VenaCure EVLT NeverTouch Procedure KitGEX · Traditional | 08/24/2017SE |
| K170775 | Mini Stick ENVI Non-Vascular Introducer KitDYB · Traditional | 07/19/2017SE |
| K170695 | VenaCure EVLT NeverTouch Direct Introducer SheathDYB · Traditional | 05/30/2017SE |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion SystemQEY · Traditional | 05/30/2017SE |
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave…NEY · Traditional | 05/05/2017SE |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersDQO · Traditional | 04/28/2017SE |
| K170743 | AngioDynamics Total Abscession Biliary Drainage CatheterFGE · Special | 03/30/2017SE |
| K170258 | SpeedLyser Infusion Catheter KitQEY · Special | 02/21/2017SE |
| K163141 | NAMIC ClearaCIL Contrast Injection LinesDQO · Traditional | 01/06/2017SE |
| K162914 | VenaCure EVLT NeverTouch Procedure KitGEX · Special | 11/16/2016SE |
| K151724 | AngioDynamics Mariner Angiographic CathetersDQO · Special | 10/14/2015SE |
| K150089 | NanoKnife SystemOAB · Traditional | 06/18/2015SE |
| K142889 | Celerity PICC Tip Confirmation SystemLJS · Traditional | 01/27/2015SE |
| K142607 | AngioVac CircuitDWE · Traditional | 12/11/2014SE |
| K142593 | AngioVac CannulaDWF · Traditional | 11/12/2014SE |
| K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure KitsGEX · Special | 10/10/2014SE |
| K133561 | Venacure Evlt Nevertouch Procedure Kit, Venacure Evlt Tre' SheathGEX · Special | 12/19/2013SE |
| K130671 | Venacure Evlt Nevertouch Procedure KitGEX · Special | 03/26/2013SE |
| K112452 | Angiodynamics Soft-Vu Angiographic CathetersDQO · Special | 03/30/2012SE |
| K112600 | Angiodynamics, Inc. Venacure Nevertouch Direct Procedure KitGEX · Traditional | 01/30/2012SE |
| K102329 | Nanoknife SystemOAB · Traditional | 10/24/2011SE |
| K110936 | Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitMSD · Traditional | 06/10/2011SESK |
| K110225 | Angiodynamics, Inc. Venacure 1470 LaserGEX · Traditional | 05/13/2011SE |
| K102796 | Angiodynamics, Inc. Venacure Procedure KitGEX · Traditional | 12/15/2010SE |
| K100199 | Angiodynamics, Inc., Percutaneous Introducer and Venacureevlt Procedure KitGEX · Traditional | 11/26/2010SE |
| K101843 | Duramax Chronic Hemodialysis Catheter and Procedure KitMSD · Traditional | 10/20/2010SESK |
| K101017 | Angiodynamics, Inc., Smart Port CT Series Port Access SystemsLJT · Special | 06/17/2010SE |
| K093406 | Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519LJS · Special | 03/25/2010SE |
| K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…LJT · Traditional | 09/23/2008SE |
| K080451 | Uniblate Electrosurgical DeviceGEI · Traditional | 07/03/2008SE |
| K080287 | Oncobionic Bipolar ElectrodeGEI · Traditional | 07/03/2008SE |
| K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitMSD · Traditional | 05/13/2008SE |
| K073464 | Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitGEX · Special | 01/23/2008SE |
| K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetFPA · Traditional | 12/13/2007SE |
| K072196 | Angiodynamics, Inc Morpheus Picc and Procedure KitLJS · Special | 08/27/2007SE |
| K071959 | Angiodynamics, Inc.Nevertouch 600UM Fiber and Venacure Procedure KitGEX · Special | 08/01/2007SE |
| K070613 | Angiodynamics, Inc., Morpheus CT Picc and Procedure KitLJS · Traditional | 06/29/2007SE |
| K070615 | Angiodynamics, Inc., Morpheus CT Picc and Procedure KitLJS · Traditional | 05/04/2007SE |
| K070378 | Angiodynamics, Inc. 600UM Fiber and Venacure Procedure KitGEX · Special | 03/09/2007SE |
| K062609 | Modification to Angiodynamics Profiler Pta Balloon CatheterDQY · Special | 10/06/2006SE |
| K061733 | Angiodynamics Soft-Vu and Mariner Hydrophilic Coated Angiographic CatheterDQO · Special | 08/24/2006SE |
| K061178 | Angiodynamics, Inc. Venacure Procedure KitGEX · Traditional | 06/12/2006SE |
| K060887 | Angiodynamic, Inc. Morpheus CT Picc and Procedure KitLJS · Special | 04/28/2006SE |
| K060023 | Angiodynamics Total Abscession Biliary Drainage CatheterFGE · Special | 03/09/2006SE |
| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | 09/12/2005SE |
| K051142 | Angiodynamics Tumescent Infusion DeviceFPA · Traditional | 07/13/2005SE |
| K051060 | Angiodynamics Profiler Pta Balloon CatheterDQY · Special | 05/26/2005SE |
| K041420 | Angiodynamics, Inc. Morpheus Picc and Procedure KitLJS · Traditional | 07/26/2004SE |
| K040728 | Angiodynamics, Inc., Percutaneous Introducer and Elvs Procedure KitDYB · Traditional | 06/18/2004SE |
| K040402 | Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure KitMSD · Traditional | 04/19/2004SE |
| K040446 | Angiodynamics, Inc. Morpheus Picc and Procedure KitLJS · Special | 03/05/2004SE |
| K033443 | Speedlyser Infusion Catheter KitQEY · Special | 11/19/2003SEKD |
| K032069 | Workhorse II Percutaneous Transluminal Angioplasty Balloon CatheterDQY · Special | 08/27/2003SE |
| K032376 | Angiodynamics Accu-Vu Sizing Angiographic CatheterDQO · Special | 08/26/2003SE |
| K031626 | Angiodynamics, Inc. Morpheus Picc and Procedure KitLJS · Special | 06/19/2003SE |
| K031233 | Andiodynamics, Inc. Elvs Procedure KitGEX · Traditional | 06/18/2003SE |
| K030415 | Angiodynamics, Inc. Morpheus Picc and Procedure KitLJS · Traditional | 04/30/2003SE |
| K003901 | Angiodynamics Soft-Vu Sizing Angiographic CatheterDQO · Special | 01/17/2001SE |
| K001578 | Angiodynamics Soft-Vu Hydrophilic Coated Angiographic CatheterDQO · Special | 10/13/2000SE |
| K002101 | Angiodynamics Abscession Biliary Drainage CatheterFGE · Traditional | 07/31/2000SE |
| K991540 | Workhorse Percutaneous Transluminal Angioplasty Balloon CatheterLIT · Traditional | 09/29/1999SE |
| K991793 | Angiodynamics Balloon Expandable Biliary Stent SystemFGE · Special | 06/25/1999SE |
| K982346 | Angiodynamics Angiostent Biliary Stent SystemFGE · Traditional | 01/29/1999SESU |
| K971314 | Dcat Embolectomy Catheter SystemDXE · Traditional | 03/17/1998SE |
| K963574 | Pulse*Spray InjectorFRN · Traditional | 07/18/1997ST |
| K964034 | Transjugular Access SetDYB · Traditional | 05/06/1997SE |
| K964033 | 3F Angioptic Angiographic CatheterDQO · Traditional | 05/06/1997SE |
| K953825 | Angioflush II Fluid Management SystemFPA · Traditional | 02/26/1996SE |
| K953384 | Multi Side Hole lnfusion SystemQEY · Traditional | 12/22/1995SE |
| K954423 | Angioptic Angiographic CatheterDQO · Traditional | 12/01/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1875-2026 Class II | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1874-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1873-2026 Class II | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1872-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1871-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1870-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1869-2026 Class II | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1868-2026 Class II | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1867-2026 Class II | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1866-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1865-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1864-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1863-2026 Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1862-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1861-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1860-2026 Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1859-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1858-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1857-2026 Class II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1856-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1391-2025 Class II | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog…Product is mislabeled with the incorrect fill volume. | 02/04/2025Open, Classified |
| Z-0770-2025 Class II | AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the… | 11/25/2024Open, Classified |
| Z-2454-2024 Class II | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog…Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner… | 06/18/2024Open, Classified |
| Z-2453-2024 Class II | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog…Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner… | 06/18/2024Open, Classified |
| Z-2267-2024 Class II | IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon… | 05/21/2024Open, Classified |
| Z-1774-2024 Class II | BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1773-2024 Class II | DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1772-2024 Class II | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining…XXX | 03/18/2024Open, Classified |
| Z-1771-2024 Class II | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1770-2024 Class II | DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1769-2024 Class II | DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1768-2024 Class II | DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1767-2024 Class II | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1766-2024 Class II | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1765-2024 Class II | DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1764-2024 Class II | DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1763-2024 Class II | DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1762-2024 Class II | DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1761-2024 Class II | DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1760-2024 Class II | DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular…Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize… | 03/18/2024Open, Classified |
| Z-1348-2024 Class II | MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1347-2024 Class II | MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1346-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1345-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1344-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1343-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1342-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1341-2024 Class II | MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1340-2024 Class II | MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1339-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1338-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1337-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1336-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1335-2024 Class II | MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1334-2024 Class II | MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | 01/30/2024Open, Classified |
| Z-1010-2024 Class II | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045…Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during… | 12/18/2023Open, Classified |
| Z-1381-2023 Class II | NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation…Not programmed in accordance with specification. The programming affects the RFID function and does not… | 03/02/2023Open, Classified |
| Z-0132-2023 Class II | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter…Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings… | 09/20/2022Open, Classified |
| Z-1819-2022 Class II | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box…OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional… | 08/10/2022Open, Classified |
| Z-2439-2021 Class II | Solero Generator PG, Item No. H78712740000, Catalog No. 12740000Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce… | 07/20/2021Terminated |
| Z-2438-2021 Class II | Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000DSpecific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce… | 07/20/2021Terminated |
| Z-2437-2021 Class II | Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000USSpecific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce… | 07/20/2021Terminated |
| Z-2436-2021 Class II | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USDSpecific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce… | 07/20/2021Terminated |
| Z-0418-2021 Class II | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction…5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component | 10/14/2020Terminated |
| Z-2398-2020 Class II | BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-2397-2020 Class II | BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-2396-2020 Class II | BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-2395-2020 Class II | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These…Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD… | 05/04/2020Terminated |
| Z-0073-2022 Class II | AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation…Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be… | 04/24/2020Terminated |
| Z-0713-2020 Class II | MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0712-2020 Class II | MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0711-2020 Class II | MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0710-2020 Class II | OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage:…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0709-2020 Class II | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F -…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-2444-2019 Class II | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE…The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed… | 06/27/2019Terminated |
| Z-0742-2018 Class II | Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB…Product was placed into distribution prior to completion of all required post sterilization release… | 09/22/2017Terminated |
| Z-0531-2018 Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0530-2018 Class II | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0529-2018 Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0528-2018 Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0527-2018 Class II | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0526-2018 Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)…The firm is recalling product that has the potential to not function during use. The product affected by… | 06/05/2017Terminated |
| Z-0778-2017 Class III | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0777-2017 Class II | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0776-2017 Class III | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0775-2017 Class III | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0774-2017 Class III | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0773-2017 Class III | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-0772-2017 Class III | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened…Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the… | 09/28/2016Terminated |
| Z-1346-2016 Class II | NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN…Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended… | 11/03/2015Terminated |
| Z-1345-2016 Class II | NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094…Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended… | 11/03/2015Terminated |
| Z-1344-2016 Class II | NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN…Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended… | 11/03/2015Terminated |
| Z-1343-2016 Class II | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311…Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended… | 11/03/2015Terminated |
| Z-1143-2015 Class II | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No.…Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually… | 12/19/2014Terminated |
| Z-2262-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | 08/06/2014Terminated |
| Z-2261-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | 08/06/2014Terminated |
| Z-2260-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | 08/06/2014Terminated |
| Z-1675-2013 Class II | AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are…The RITA Main Cable product contains the incorrect Instructions for Use. | 06/11/2013Terminated |
| Z-1406-2013 Class II | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling:…AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because… | 04/30/2013Terminated |
| Z-1405-2013 Class II | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F…AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because… | 04/30/2013Terminated |
| Z-0056-2012 | 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The…The product may contain an incorrect size catheter and introducer. | 08/01/2011Terminated |
| Z-0055-2012 | 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved…The product may contain an incorrect size catheter and introducer. | 08/01/2011Terminated |
| Z-3258-2011 | ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603…Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error.… | 04/04/2011Terminated |
| Z-0590-2012 | DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip)…AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 01/24/2011Terminated |
| Z-0589-2012 | DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip)…AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 01/24/2011Terminated |
| Z-0588-2012 | DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip)…AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 01/24/2011Terminated |
| Z-0587-2012 | DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip)…AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 01/24/2011Terminated |
| Z-0586-2012 | DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip)…AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 01/24/2011Terminated |
| Z-0406-2011 | Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0405-2011 | LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0404-2011 | Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0403-2011 | Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0402-2011 | Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-3074-2011 | Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-3073-2011 | Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-3072-2011 | Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-3071-2011 | Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-1707-2010 | PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402…This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length… | 05/17/2010Terminated |
| Z-1734-2010 | ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion…Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product… | 04/30/2010Terminated |
| Z-1733-2010 | ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion…Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product… | 04/30/2010Terminated |
| Z-1771-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1770-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1769-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1768-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1767-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1766-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1765-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1764-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1763-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1762-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1761-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1898-2009 | SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The…The product may contain an incorrect size catheter and introducer. | 07/16/2009Terminated |
| Z-2398-2008 | Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From…The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at… | 07/07/2008Terminated |
| Z-2397-2008 | Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From…The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at… | 07/07/2008Terminated |
| Z-2396-2008 | Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From…The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at… | 07/07/2008Terminated |