Catheter, Peripheral, Atherectomy
FDA product code MCW · Class II (moderate risk) · 21 CFR 870.4875 · Cardiovascular
146510(k) clearances
0PMA approvals
31recalls
Manufacturers
- Cardiovascular Systems, Inc. 21
- Pathway Medical Technologies, Inc. 16
- Avinger, Inc. 10
- Spectranetics Corp. 10
- Eximo Medical, Ltd. 8
- Volcano Atheromed, Inc. 6
- Rex Medical 5
- Boston Scientific Corporation 5
- Ev3, Inc. 4
- Fox Hollow Technologies 4
- Cardio Flow Inc., 4
- Microvena Corp. 3
- Heart Technology Mfg., Inc. 3
- Medrad, Inc. 3
- Bacchus Vascular, Inc. 3
- Rex Medical, L.P. 3
- Heart Technology, Inc. 3
- Foxhollow Technologies, Inc. 2
- Cardio Systems, Inc. 2
- Dow Corning Wright 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | Avinger, Inc. | 06/06/2023SE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | Spectranetics, Inc. | 12/08/2022SE |
| K220116 | Auryon Atherectomy CathetersMCW · Traditional | Eximo Medical, Ltd. | 09/26/2022SE |
| K220962 | ROTAPRO Rotational Atherectomy SystemMCW · Traditional | Boston Scientific Corporation | 09/06/2022SE |
| K221077 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical, Ltd. | 06/09/2022SE |
| K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…MCW · Traditional | Cardiovascualr Systems, Inc. | 04/27/2022SE |
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Special | Cardiovascular Systems, Inc. | 03/01/2022SE |
| K212351 | Revolution Peripheral Atherectomy SystemMCW · Traditional | Rex Medical, L.P. | 12/15/2021SE |
| K212047 | Pantheris SystemMCW · Traditional | Avinger, Inc. | 11/16/2021SE |
| K211738 | Rotarex Atherectomy SystemMCW · Traditional | C.R. Bard, Inc. | 09/14/2021SE |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…MCW · Special | Cardiovascular Systems, Inc. | 09/14/2021SE |
| K212027 | TurboHawk Plus Directional Atherectomy SystemMCW · Traditional | Medtronic, Inc. | 08/24/2021SE |
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…MCW · Special | Volcano Atheromed, Inc. | 06/14/2021SE |
| K202835 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 12/02/2020SE |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Traditional | Cardiovascular Systems, Inc. | 11/19/2020SE |
| K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireMCW · Traditional | Rex Medical, L.P. | 09/12/2019SE |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…MCW · Traditional | Cardiovascular Systems, Inc. | 07/02/2019SE |
| K182341 | Pantheris SVMCW · Traditional | Avinger, Inc. | 04/09/2019SE |
| K182972 | Phoenix Atherectomy SystemMCW · Special | Volcano Atheromed, Inc. | 12/20/2018SE |
| K181877 | Phoenix 2.4mm Atherectomy Plus SystemMCW · Traditional | Volcano Atheromed, Inc. | 12/17/2018SE |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW · Traditional | Cardiovascular Systems, Inc. | 12/13/2018SE |
| K181642 | B-Laser Atherectomy SystemMCW · Traditional | Eximo Medical, Ltd. | 10/05/2018SE |
| K173862 | Pantheris SystemMCW · Traditional | Avinger, Inc. | 05/22/2018SE |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…MCW · Traditional | Cardiovascular Systems, Inc. | 04/17/2018SE |
| K172315 | Straub Endovascular SystemMCW · Traditional | Straub Medical AG | 04/12/2018SE |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | Spectranetics, Inc. | 04/05/2018SE |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Traditional | Spectranetics, Inc. | 11/27/2017SE |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…MCW · Special | Avinger, Inc. | 10/30/2017SE |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…MCW · Special | Volcano Atheromed, Inc. | 08/24/2017SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | Medtronic Vascular, Inc. | 06/16/2017SE |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 06/09/2017SE |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW · Traditional | Spectranetics, Inc. | 04/07/2017SE |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW · Traditional | Spectranetics, Inc. | 01/05/2017SE |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW · Special | Avinger, Inc. | 12/21/2016SE |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledMCW · Traditional | Avinger, Inc. | 10/18/2016SE |
| K161361 | HawkOne Directional Atherectomy SystemMCW · Traditional | Medtronic Vascular, Inc. | 10/14/2016SE |
| K160827 | Pantheris CatheterMCW · Special | Avinger, Inc. | 04/21/2016SE |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)MCW · Traditional | Avinger, Inc. | 03/01/2016SE |
| K152181 | Turbo-Power Laser Atherectomy CatheterMCW · Traditional | Spectranetics, Inc. | 11/12/2015SE |
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 10/21/2015SE |
| K152275 | Pantheris SystemMCW · Traditional | Avinger, Inc. | 10/14/2015SE |
| K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…MCW · Special | Cardiovascular System, Inc. | 06/10/2015SE |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMCW · Special | Volcano Atheromed, Inc. | 05/26/2015SE |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 04/13/2015SE |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…MCW · Special | Volcano Atheromed, Inc. | 12/19/2014SE |
| K141801 | Hawkone Directional Atherectomy SystemMCW · Traditional | Covidien, LLC | 10/16/2014SE |
| K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6MCW · Traditional | Medrad, Inc. | 08/27/2014SE |
| K140944 | 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…MCW · Special | Atheromed, Inc. | 08/22/2014SE |
| K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemMCW · Traditional | Spectranetics Corporation | 07/23/2014SE |
| K133999 | Diamondback 360 Peripheral Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 02/28/2014SE |
| K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…MCW · Traditional | Atheromed, Inc. | 01/17/2014SE |
| K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink PlusMCW · Special | Boston Scientific Corp | 12/20/2013SE |
| K133399 | Diamondback 360 Peripheral Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems Incorporated | 11/22/2013SE |
| K131092 | Stealth 360 Orbital Pad SystemMCW · Special | Cardio Systems, Inc. | 06/24/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | Medrad, Inc. | 04/10/2013SE |
| K123632 | 2.5MM Turbo Elite 035, 2.3MM Turbo Elite 035MCW · Traditional | Spectranetics Corp. | 01/25/2013SE |
| K122987 | Stealth 360 Orbital Pad SystemMCW · Special | Cardiovascular Systems, Inc. | 10/25/2012SE |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…MCW · Special | Medrad, Inc. | 10/19/2012SE |
| K121774 | Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusMCW · Traditional | Boston Scientific Corp | 09/13/2012SE |
| K120346 | Cleaner Rotational Thrombectomy SystemMCW · Traditional | Rex Medical | 06/01/2012SE |
| K120242 | Jetstream Navitus L SystemMCW · Special | Pathway Medical Technologies, Inc. | 02/24/2012SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | Ev3, Inc. | 10/27/2011SE |
| K111388 | Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemMCW · Traditional | Cardiovascular Systems, Inc. | 07/26/2011SE |
| K111229 | Jetstream G3 (R) SF 1.6 SystemMCW · Special | Pathway Medical Technologies, Inc. | 06/01/2011SE |
| K110626 | Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 Se System; Jetstream G3 L…MCW · Special | Pathway Medical Technologies, Inc. | 04/20/2011SE |
| K110389 | Stealth 360 Orbital Pad SystemMCW · Special | Cardiovascular Systems, Inc. | 03/11/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | Ev3, Inc. | 01/05/2011SE |
| K101334 | Jetstream G3 Se System, Jetstream G3 SF System Model PV31230 (Jetstream G3 Se Catheter…MCW · Special | Pathway Medical Technologies, Inc. | 06/11/2010SE |
| K101221 | Jetstream G3 System, Model PV31300, PV Console, Model PVCN100MCW · Special | Pathway Medical Technologies, Inc. | 06/02/2010SE |
| K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100MCW · Traditional | Pathway Medical Technologies, Inc. | 05/19/2010SE |
| K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)MCW · Traditional | Rex Medical | 02/18/2010SE |
| K094036 | Turbo-Tandem System Model 472-110MCW · Special | Spectranetics Corp. | 01/25/2010SE |
| K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…MCW · Special | Pathway Medical Technologies, Inc. | 01/21/2010SE |
| K093456 | Jetstream G3 SystemMCW · Special | Pathway Medical Technologies, Inc. | 12/01/2009SE |
| K093301 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | Ev3, Inc. | 11/06/2009SE |
| K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…MCW · Special | Pathway Medical Technologies, Inc. | 09/03/2009SE |
| K091509 | Jetstream G2 NXT System, Model PV20300MCW · Special | Pathway Medical Technologies, Inc. | 06/19/2009SE |
| K090521 | Diamondback 360 DBXMCW · Special | Cardiovascular Systems, Inc. | 03/20/2009SE |
| K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…MCW · Special | Pathway Medical Technologies, Inc. | 03/11/2009SE |
| K083489 | Jetstream Pathway PC Atherectomy System, Model OV10300MCW · Traditional | Pathway Medical Technologies, Inc. | 01/23/2009SE |
| K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…MCW · Special | Pathway Medical Technologies, Inc. | 01/13/2009SE |
| K082981 | Diamondback 360 Degree Orbital Atherectomy System with Viperslide LubricantMCW · Special | Cardiovascular Systems, Inc. | 10/31/2008SE |
| K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100MCW · Special | Pathway Medical Technologies, Inc. | 10/06/2008SE |
| K082186 | Modification to Pathway PV Atherectomy SystemMCW · Special | Pathway Medical Technologies, Inc. | 08/29/2008SE |
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy SystemMCW · Special | Cardio Systems, Inc. | 08/14/2008SE |
| K081328 | Pathway PV Atherectomy SystemMCW · Traditional | Pathway Medical Technologies, Inc. | 07/17/2008SE |
| K071432 | Silverhawk-R Peripheral Plaque Excision System for Surgical UseMCW · Traditional | Fox Hollow Technologies | 02/12/2008SE |
| K072748 | Modification to: Diamondback 360 Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 11/09/2007SE |
| K072800 | Diamondback 360 Degree Orbital Atherectomy SystemMCW · Special | Cardiovascular Systems, Inc. | 10/25/2007SE |
| K071427 | Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt StenosisMCW · Special | Cardiovascular Systems, Inc. | 08/30/2007SE |
| K072195 | Thromcat Thrombectomy Catheter SystemMCW · Special | Kensey Nash Corp. | 08/23/2007SE |
| K071350 | Diamondback 360 Degree Orbital Atherectomy SystemMCW · Traditional | Cardiovascular Systems, Inc. | 08/22/2007SE |
| K061188 | Silverhawk Peripheral Plaque Excision SystemMCW · Traditional | Foxhollow Technologies, Inc. | 10/23/2006SE |
| K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300MCW · Special | Foxhollow Technologies, Inc. | 05/18/2006SE |
| K060904 | Cleaner Rotational Thrombectomy SystemMCW · Special | Rex Medical, L.P. | 04/28/2006SE |
| K060016 | Thromcat Thrombectomy Catheter SystemMCW · Traditional | Kensey Nash Corp. | 04/25/2006SE |
| K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…MCW · Special | Fox Hollow Technologies | 01/13/2006SE |
| K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…MCW · Special | Fox Hollow Technologies | 02/18/2005SE |
| K041630 | Orbital Atherectomy System for Treatment of A-V Shunt StenosisMCW · Abbreviated | Cardiovascular Systems Incorporated | 01/31/2005SE |
| K021096 | X-Sizer Catheter SystemMCW · Traditional | Ev3 Corporation | 09/08/2004SE |
| K040252 | Cleaner Rotational Thrombectomy System KitMCW · Special | Rex Medical | 02/26/2004SE |
| K033997 | Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007…MCW · Special | Bacchus Vascular, Inc. | 02/04/2004SE |
| K033793 | Cleaner II Rotational Thrombectomy SystemMCW · Traditional | Rex Medical | 12/16/2003SE |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060MCW · Traditional | Idev Technologies, Inc. | 09/16/2003SE |
| K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…MCW · Traditional | Fox Hollow Technologies | 06/20/2003SE |
| K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemMCW · Traditional | Rex Medical | 05/27/2003SE |
| K022640 | Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum…MCW · Special | Bacchus Vascular, Inc. | 12/02/2002SE |
| K013473 | XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model #…MCW · Traditional | Xtrak Medical, Inc. | 03/06/2002SE |
| K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755MCW · Traditional | Bacchus Vascular, Inc. | 06/06/2001SE |
| K993816 | Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDMCW · Traditional | Baxter Edwards | 05/04/2000SE |
| K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002MCW · Traditional | Possis Medical, Inc. | 04/28/2000SE |
| K993648 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterMCW · Special | Boston Scientific Corporation Northwest Technology | 11/24/1999SE |
| K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit…MCW · Special | Arrow Intl., Inc. | 05/04/1999SE |
| K982363 | Oasis Thrombectomy Catheter SystemMCW · Traditional | Boston Scientific Corp | 02/23/1999SE |
| K982657 | Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal…MCW · Traditional | Microvena Corp. | 11/18/1998SE |
| K973669 | Thrombolytic Brush Catheter, Over the Wire (Otw)MCW · Traditional | Micro Therapeutics, Inc. | 02/06/1998SE |
| K970233 | Gelbfish Endo-Vac SystemMCW · Traditional | Gary A. Gelbfish | 10/08/1997SESK |
| K971984 | Amplatz Thrombectomy Device(Atd 603,602,801,802)/FOOT Pedal Assembly(Ak 200)MCW · Traditional | Microvena Corp. | 09/19/1997SE |
| K970296 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterMCW · Traditional | Boston Scientific Corp | 08/29/1997SE |
| K963925 | Thrombolytic Brush CatheterMCW · Traditional | Micro Therapeutics, Inc. | 08/08/1997SE |
| K970080 | Arrow-Trerotola PTD CatheterMCW · Traditional | Arrow Intl., Inc. | 07/25/1997SE |
| K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…MCW · Traditional | Possis Medical, Inc. | 12/03/1996SE |
| K954205 | The Amplatz Thrombectomy DeviceMCW · Traditional | Microvena Corp. | 08/13/1996SE |
| K960379 | Rotablator System's Guide Wire Line: Support Rotawire Rail Rota WireMCW · Traditional | Heart Technology Mfg., Inc. | 04/25/1996SE |
| K954604 | Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti FloppyMCW · Traditional | Heart Technology Mfg., Inc. | 01/18/1996SE |
| K953997 | Rotablator Rotational AngioplastyMCW · Traditional | Heart Technology Mfg., Inc. | 12/22/1995SE |
| K942457 | Graft Thrombectomy InstrumentsMCW · Traditional | Intramed Laboratories, Inc. | 02/07/1995SE |
| K935929 | MicrotrackMCW · Traditional | Devices For Vascular Intervention, Inc. | 03/10/1994SE |
| K933238 | Rotablator, ModificationMCW · Traditional | Heart Technology, Inc. | 08/24/1993SE |
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | Intensive Technology, Inc. | 01/13/1993SE |
| K924712 | Rotablator Rotational Angioplasty SystemMCW · Traditional | Hearing Tech, Inc. | 12/08/1992SE |
| K920707 | Hollow Motor Drive Unit W/ Torque ControllerMCW · Traditional | Devices For Vascular Intervention, Inc. | 11/23/1992SE |
| K915238 | Trac-Wright Trac 10 CatheterMCW · Traditional | Dow Corning Wright | 02/19/1992SE |
| K913450 | Heart Technology Rotablator WireclipMCW · Traditional | Heart Technology, Inc. | 09/06/1991SE |
| K904680 | Theratek Group Exchange CatheterMCW · Traditional | Dow Corning Wright | 12/27/1990SE |
| K901206 | RotablatorMCW · Traditional | Heart Technology, Inc. | 09/14/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1244-2025 Class I | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm…Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the… | Bard Peripheral Vascular Inc | 02/05/2025Open, 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… | Angiodynamics, Inc. | 11/25/2024Open, Classified |
| Z-0680-2025 Class II | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description…Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining… | Spectranetics Corporation | 11/25/2024Open, Classified |
| Z-0509-2024 Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics…Incorrect product labeling. Exterior product box label does not match internal pouch label. | Spectranetics Corporation | 11/15/2023Open, Classified |
| Z-0695-2022 Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number…The device has similarities in design to another device that the firm recently issued a field correction on… | ev3 Inc. | 02/04/2022Terminated |
| Z-0694-2022 Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number…The device has similarities in design to another device that the firm recently issued a field correction on… | ev3 Inc. | 02/04/2022Terminated |
| Z-0451-2022 Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT…Reports have been received of tip damage during use of the devices which resulted in some instances of tip… | ev3 Inc. | 12/06/2021Terminated |
| Z-0450-2022 Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.…Reports have been received of tip damage during use of the devices which resulted in some instances of tip… | ev3 Inc. | 12/06/2021Terminated |
| Z-2386-2021 Class II | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF…There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm… | Cardiovascular Systems Inc | 07/21/2021Terminated |
| Z-2385-2021 Class II | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF…There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm… | Cardiovascular Systems Inc | 07/21/2021Terminated |
| Z-3022-2018 Class II | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED…The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 08/10/2018Terminated |
| Z-0506-2018 Class II | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system…Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for… | Cardiovascular Systems Inc | 09/14/2017Terminated |
| Z-0505-2018 Class II | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system…Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for… | Cardiovascular Systems Inc | 09/14/2017Terminated |
| Z-2863-2017 Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters…Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy… | Spectranetics Corporation | 06/06/2017Terminated |
| Z-1922-2017 Class II | The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking…Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of… | Boston Scientific Corporation | 04/05/2017Terminated |
| Z-1771-2017 Class II | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized…Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18… | Cardiovascular Systems Inc | 03/03/2017Terminated |
| Z-1877-2017 Class II | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number:…CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was… | Cardiovascular Systems Inc | 02/09/2017Terminated |
| Z-1230-2017 Class II | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital…CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. | Cardiovascular Systems Inc | 12/07/2016Terminated |
| Z-0661-2017 Class II | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | Spectranetics Corporation | 10/31/2016Terminated |
| Z-2051-2016 Class II | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part…The pouch label was missing the use by date (UBD) of 2018-04. | Cardiovascular Systems Inc | 06/13/2016Terminated |
| Z-0758-2016 Class II | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System…The product is labeled with an expiration date that is past its shelf life. | Spectranetics Corp. | 01/15/2016Terminated |
| Z-2155-2014 Class I | CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System…CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may… | Cardiovascular Systems, Inc. | 05/23/2014Terminated |
| Z-1143-2013 Class II | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon…Distribution of an unapproved device into interstate commerce. | Elana, Inc. | 02/14/2013Terminated |
| Z-1959-2012 Class II | CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model…CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which… | Cardiovascular Systems, Inc. | 06/18/2012Terminated |
| Z-1162-2010 | SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550…ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG… | Ev3, Inc. | 01/21/2010Terminated |
| Z-2028-2009 | Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part #…CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The… | Cardiovascular Systems, Inc. | 04/16/2009Terminated |
| Z-1250-2009 | Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM.…CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The… | Cardiovascular Systems, Inc. | 03/16/2009Terminated |
| Z-1501-2009 | Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis graftsLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | Arrow International Inc | 02/11/2009Terminated |
| Z-0279-2009 | Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD…The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of… | Cordis Corporation | 08/20/2008Terminated |
| Z-1115-2007 | ThromCat Thrombectomy Catheter System. Catalog number 63000-01Defective component (power supply) | Kensey Nash Corp | 05/21/2007Terminated |
| Z-0597-2007 | ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01.…Face seal may wear excessively and cause particulate matter. | Kensey Nash Corp | 02/07/2007Terminated |