Stent, Ureteral
FDA product code FAD · Class II (moderate risk) · 21 CFR 876.4620 · Gastroenterology, Urology
122510(k) clearances
0PMA approvals
53recalls
Implantimplanted device
Manufacturers
- Cook, Inc. 13
- Boston Scientific Corporation 12
- Surgitek 9
- Mentor Corp. 8
- C.R. Bard, Inc. 7
- Coloplast Corp. 7
- Medical Engineering Corp. 5
- Applied Medical Resources Corp 5
- Cook Urological, Inc. 5
- Van-Tec, Inc. 3
- Urosurge, Inc. 3
- Q Urological Corporation 3
- Inter-Med, Inc. 2
- Vas-Cath, Inc. 2
- Angiomed U.S., Inc. 2
- Fossa Industries, Inc. 2
- Menlo Care, Inc. 2
- Fossa Medical, Inc. 2
- Applied Urology, Inc. 2
- Ureteral Stent Company 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| K251469 | Endura Ureteral Stent and Stent SetFAD · Traditional | Cathegenix (Xiamen) Co., Ltd. | 12/19/2025SESK |
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 06/18/2025SE |
| K243830 | Disposable ureteral stentFAD · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 05/14/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | Boston Scientific Corporation | 04/15/2025SE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/22/2024SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | Boston Scientific Corporation | 11/10/2022SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | Coloplast Corp. | 06/08/2022SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/17/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | Coloplast Corp. | 02/16/2022SESK |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KITFAD · Traditional | Rocamed Sam | 01/26/2022SE |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex…FAD · Traditional | Boston Scientific Corporation | 04/26/2021SESK |
| K201436 | Vortek Single Loop Ureteral StentFAD · Traditional | Coloplast Corp. | 02/25/2021SE |
| K191446 | Ureteral Stent Systems, Biliary Drainage CathetersFAD · Traditional | Boston Scientific Corporation | 01/02/2020SESK |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via…FAD · Traditional | Allwin Medical Devices, Inc. | 12/02/2019SESK |
| K190312 | Dornier Ureteral StentFAD · Traditional | Dornier Medtech America, Inc. | 11/15/2019SE |
| K191609 | Tria Soft Ureteral StentFAD · Traditional | Boston Scientific Corporation | 08/16/2019SE |
| K190603 | Tria Firm Ureteral StentFAD · Special | Boston Scientific Corporation | 05/24/2019SE |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent SetFAD · Traditional | Cook Incorporated | 04/23/2019SESK |
| K180557 | Greene Renal Transplant Stent SetFAD · Traditional | Cook Incorporated | 11/23/2018SE |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD · Traditional | Coloplast Corp. | 11/06/2018SE |
| K180216 | Seidmon Antegrade AQ Stent SetFAD · Traditional | Cook Incorporated | 09/28/2018SE |
| K180029 | Malecot Nephrostomy Catheter/Stent SetFAD · Traditional | Cook Incorporated | 09/21/2018SE |
| K180053 | Sof-Flex Ureteral Stent SetFAD · Traditional | Cook Incorporated | 09/13/2018SE |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetFAD · Traditional | Cook Incorporated | 04/16/2018SESK |
| K172017 | Black Silicone Filiform Double Pigtail Stent SetFAD · Traditional | Cook Incorporated | 03/26/2018SESK |
| K173734 | RocaJJ Soft StentsFAD · Traditional | Promepla Sam | 03/12/2018SE |
| K180057 | Vortek Ureteral Double Loop StentFAD · Traditional | Coloplast Corp. | 03/09/2018SE |
| K170362 | Vortek Hydro-Coated Double Loop Ureteral StentsFAD · Traditional | Coloplast Corp. | 11/15/2017SE |
| K170422 | Biosoft Duo Double Loop Ureteral StentsFAD · Traditional | Coloplast Corp. | 11/02/2017SE |
| K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentFAD · Special | Q Urological Corporation | 10/04/2017SE |
| K170010 | Salle Intraoperative Pyeloplasty Stent SetFAD · Traditional | Cook Incorporated | 08/28/2017SE |
| K163399 | Tria Firm Ureteral StentFAD · Traditional | Boston Scientific Corporation | 06/22/2017SE |
| K162109 | Kwart Retro-Inject Ureteral StentFAD · Traditional | Cook Incorporated | 06/07/2017SE |
| K162104 | C-Flex Ureteral Stent SetFAD · Traditional | Cook Incorporated | 04/24/2017SESK |
| K161236 | Universa Firm Ureteral Stents and Stent SetsFAD · Traditional | Cook Incorporated | 01/27/2017SE |
| K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentFAD · Special | Q Urological Corporation | 12/22/2016SE |
| K161277 | ConvertX Nephroureteral Stent SystemFAD · Traditional | Brightwater Medical | 11/22/2016SE |
| K160891 | Ultrathane Endoureterotomy Stent SetFAD · Traditional | Cook Incorporated | 06/24/2016SE |
| K151051 | Universa Soft Ureteral Stents and Stent SetsFAD · Traditional | Cook Incorporated | 01/11/2016SE |
| K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…FAD · Traditional | Boston Scientific Corp | 10/17/2014SE |
| K082805 | Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXXFAD · Traditional | Q Urological Corporation | 01/20/2010SE |
| K072293 | Fossa Ureteral Open StentsFAD · Traditional | Fossa Medical, Inc. | 08/06/2008SE |
| K063742 | Resonance Metallic Ureteral StentFAD · Traditional | Cook Ireland, Ltd. | 05/08/2007SE |
| K060673 | Pediatric Ureteral StentFAD · Traditional | Applied Medical Resources Corp. | 03/29/2006SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | Bioteque Corp. | 12/30/2004SE |
| K043193 | Bard Inlayoptima Ureteral Stent with SutureFAD · Special | C.R. Bard, Inc. | 12/07/2004SE |
| K040760 | Modification to Ureteral StentFAD · Special | Applied Medical Resources Corp. | 10/15/2004SE |
| K031292 | Modification to Fossa Ureteral Stone SweeperFAD · Special | Fossa Medical, Inc. | 05/22/2003SE |
| K030503 | Modification to Contour Polaris Ureteral StentFAD · Special | Boston Scientific Corp | 03/17/2003SE |
| K022447 | Bard Er Ureteral Stent with SutureFAD · Traditional | C.R. Bard, Inc. | 01/23/2003SE |
| K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XFAD · Traditional | Porges S.A. | 10/17/2002SE |
| K013784 | Ureteral StentFAD · Traditional | Boston Scientific Corp | 08/08/2002SE |
| K021602 | Fossa Ureteral Stone SweeperFAD · Traditional | Fossa Industries, Inc. | 07/26/2002SE |
| K021140 | Fossa Expanding Double Pigtail Ureteral StentFAD · Traditional | Fossa Industries, Inc. | 06/28/2002SE |
| K011264 | Mesh Ureteral StentFAD · Traditional | Applied Medical Resources Corp. | 07/17/2001SE |
| K010002 | Contour Polaris Ureteral StentFAD · Special | Boston Scientific Corp | 01/22/2001SE |
| K992391 | Urosurge Spiralflo Ureteral StentFAD · Traditional | Urosurge, Inc. | 08/18/1999SE |
| K982974 | DD Ureteral Stent, Integral StentFAD · Traditional | Rusch Intl. | 07/02/1999SE |
| K991219 | C-Flex Ureteral StentsFAD · Traditional | Applied Medical Resources | 06/21/1999SE |
| K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to…FAD · Abbreviated | C.R. Bard, Inc. | 12/15/1998SE |
| K981591 | Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentFAD · Special | International Regulatory Consultants | 10/09/1998SE |
| K981491 | Urosurge Filastent Ureteral StentFAD · Traditional | Urosurge, Inc. | 05/29/1998SE |
| K981489 | Urosurge Spirastent Plus Ureteral StentFAD · Traditional | Urosurge, Inc. | 05/29/1998SE |
| K974541 | Modified Ureteral Indwelling Catheter/StentFAD · Traditional | Boston Scientific Corp | 02/09/1998SE |
| K973504 | Urosurge UrostentFAD · Traditional | Princeton Regulatory Assoc. | 01/30/1998SE |
| K961371 | Subcutaneous Urinary Diverson Stent SetFAD · Traditional | Cook Urological, Inc. | 07/24/1996SE |
| K952513 | Lese Stents SetsFAD · Traditional | Cook Urological, Inc. | 06/10/1996SE |
| K961446 | Aq Hydrophilic StentFAD · Traditional | Cook Urological, Inc. | 05/28/1996SE |
| K960148 | Circon-Surgitek Classic Double Pigtail Ureteral StentFAD · Traditional | Cabot Medical Corp. | 03/25/1996SE |
| K946296 | Quadra-Coil Ureteral StentFAD · Traditional | Surgitek | 03/06/1995SE |
| K930731 | Slip-Coat StentsFAD · Traditional | Cook Urological, Inc. | 12/08/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | Surgitek | 05/24/1994SE |
| K933941 | Menlo Care Urinary Diversion StentFAD · Traditional | Menlo Care, Inc. | 03/31/1994SE |
| K923394 | Menlo Care Aquastent SetFAD · Traditional | Menlo Care, Inc. | 11/16/1993SE |
| K930733 | Ureteral StentFAD · Traditional | Surgitek | 07/23/1993SE |
| K930882 | Urological Catheter & AccessoriesFAD · Traditional | Applied Medical Resources | 07/08/1993SE |
| K925282 | Urological Catheter and AccessoriesFAD · Traditional | Applied Urology, Inc. | 01/13/1993SE |
| K920695 | Ureteral StentFAD · Traditional | Applied Urology, Inc. | 09/23/1992SE |
| K914280 | Echosight Stent SetFAD · Traditional | Cook Urological, Inc. | 01/09/1992SE |
| K913928 | Surgitek(R) 4.5FR Lubri-Flex(Tm) Ureteral StentFAD · Traditional | Surgitek Medical Engineering Corp. | 11/19/1991SE |
| K912060 | Mentor Black Light Injection Stent SetFAD · Traditional | Mentor Corp. | 09/27/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | North American Sterilization & Packaging Co. | 08/15/1991SE |
| K903345 | Bard (R) Lubricious - Coated Ureteral Stent SutureFAD · Traditional | C.R. Bard, Inc. | 04/30/1991SE |
| K905505 | Vas-Cath Ureteral Stents Catheter, ModificationFAD · Traditional | Vas-Cath, Inc. | 04/09/1991SE |
| K905289 | Surgitek(R) Lubri-Flex(Tm) Ureteral StentFAD · Traditional | Medical Engineering Corp. | 03/13/1991SE |
| K904231 | Model Osp, Sandhill AmsFAD · Traditional | Sandhill Scientific, Inc. | 01/02/1991SE |
| K894357 | Vas-Cath Ureteral Stent CatheterFAD · Traditional | Vas-Cath, Inc. | 10/03/1989SE |
| K883561 | Bard(R) Ureteral Stent W/SutureFAD · Traditional | C.R. Bard, Inc. | 11/15/1988SE |
| K882157 | Panamex(Tm) Ureteral StentFAD · Traditional | Kingston Technologies, Inc. | 08/02/1988SE |
| K881744 | Porges Ureteral StentFAD · Traditional | Bivona Medical Technologies | 05/03/1988SE |
| K880660 | Surgitek Super Double J Ureteral Stent KitFAD · Traditional | Surgitek | 04/14/1988SE |
| K875038 | Mentor Unistent Ureteral Stent SetFAD · Traditional | Mentor Corp. | 03/03/1988SE |
| K873557 | Mentor Black Light Ureteral Stent SetFAD · Traditional | Mentor Corp. | 02/11/1988SE |
| K872353 | Surgitek Infusion Stent System*FAD · Traditional | Surgitek | 09/16/1987SE |
| K871667 | Ureteral StentFAD · Traditional | Penn Medical Devices, Inc. | 06/10/1987SE |
| K871291 | Am Cath Eswl StentFAD · Traditional | Inter-Med Corp. | 04/30/1987SE |
| K865085 | Kaminsky Combination Stent & Injection CatheterFAD · Traditional | Van-Tec, Inc. | 03/25/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | Angiomed U.S., Inc. | 01/30/1987SE |
| K864669 | Am Cath Eswl StentFAD · Traditional | Inter-Med Corp. | 01/05/1987SE |
| K863492 | Metal Tipped Ureter. Stent & Magnetic Stent Retri.FAD · Traditional | Surgitek | 12/18/1986SE |
| K862539 | Silicone Double Coil Ureteral Stent with SutureFAD · Traditional | Mentor Corp. | 09/09/1986SE |
| K861478 | Bard Double Pigtail Ureteral StentFAD · Traditional | C.R. Bard, Inc. | 05/15/1986SE |
| K860267 | Mardis Dangler Ureteral Stent SetFAD · Traditional | Van-Tec, Inc. | 04/03/1986SE |
| K854908 | UroflexFAD · Traditional | Angiomed U.S., Inc. | 03/14/1986SE |
| K860055 | Mentor Single Coil Urinary Diversion Stent SetFAD · Traditional | Mentor Corp. | 03/11/1986SE |
| K854862 | Curity Ureteral StentFAD · Traditional | The Kendal Co. | 02/10/1986SE |
| K852389 | Ureteral StentFAD · Traditional | American Medical Systems, Inc. | 09/05/1985SE |
| K851870 | Mentor Universal Ureteral Stent SetFAD · Traditional | Mentor Corp. | 07/02/1985SE |
| K850175 | Mentor Dbl-Coil Indwell. Silicone Ureteral Stent SFAD · Traditional | Mentor Corp. | 03/07/1985SE |
| K850176 | Mentor Dbl-Coil Indwelling Polyurethane Ureteral-FAD · Traditional | Mentor Corp. | 02/28/1985SE |
| K833782 | Surgitek All Silicone Infection DoubjFAD · Traditional | Surgitek | 04/02/1984SE |
| K834401 | Ureteral Double Pigtail StentFAD · Traditional | Hobbs Medical, Inc. | 03/22/1984SE |
| K840059 | Silitek Urinary Diversion StentFAD · Traditional | Surgitek | 02/04/1984SE |
| K832915 | Urethral Obstruct Primary Exchange StenFAD · Traditional | Surgitek | 10/14/1983SE |
| K831857 | Surgitek Percutaneous Arnegrade SilitekFAD · Traditional | Medical Engineering Corp. | 08/11/1983SE |
| K831446 | Surgitek Nephrostent KitFAD · Traditional | Mec/Surgitek Products | 06/22/1983SE |
| K823487 | Bard Ureteral StentFAD · Traditional | C.R. Bard, Inc. | 05/27/1983SE |
| K830884 | Surgiteks Percutaneous Antegrade All -FAD · Traditional | Medical Engineering Corp. | 05/09/1983SE |
| K820870 | Ureteral Stant SetFAD · Traditional | Van-Tec, Inc. | 04/26/1982SE |
| K800109 | Surgitek Urinary Diversion StentFAD · Traditional | Medical Engineering Corp. | 02/26/1980SE |
| K781641 | Surgitek Double J Ureterol StentFAD · Traditional | Medical Engineering Corp. | 12/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0908-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | C.R. Bard Inc | 11/06/2025Open, Classified |
| Z-0907-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | C.R. Bard Inc | 11/06/2025Open, Classified |
| Z-0906-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | C.R. Bard Inc | 11/06/2025Open, Classified |
| Z-0905-2026 Class II | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | C.R. Bard Inc | 11/06/2025Open, Classified |
| Z-0045-2023 Class II | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0044-2023 Class II | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0043-2023 Class II | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0042-2023 Class II | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0041-2023 Class II | Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0040-2023 Class II | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0039-2023 Class II | Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0038-2023 Class II | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0037-2023 Class II | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0960-2021 Class II | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde…Manufactured with incorrect material, which may result in the stent being stiffer and potentially… | Cook Inc. | 01/04/2021Terminated |
| Z-0758-2021 Class II | Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090…Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris… | Boston Scientific Corporation | 11/16/2020Open, Classified |
| Z-0757-2021 Class II | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris… | Boston Scientific Corporation | 11/16/2020Open, Classified |
| Z-2971-2020 Class II | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526…Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm… | Cook Inc. | 07/30/2020Terminated |
| Z-0978-2020 Class II | Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0977-2020 Class II | Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0976-2020 Class II | Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0975-2020 Class II | Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0974-2020 Class II | Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887…The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0973-2020 Class II | C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0406-2017 Class II | Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | C.R. Bard, Inc. | 10/13/2016Terminated |
| Z-0405-2017 Class II | Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | C.R. Bard, Inc. | 10/13/2016Terminated |
| Z-0404-2017 Class II | BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | C.R. Bard, Inc. | 10/13/2016Terminated |
| Z-0403-2017 Class II | Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | C.R. Bard, Inc. | 10/13/2016Terminated |
| Z-0852-2011 | Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R…The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually… | Vance Products Incorporated | 10/18/2010Terminated |
| Z-1347-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | Boston Scientific Corporation | 03/18/2009Terminated |
| Z-1342-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | Boston Scientific Corporation | 03/18/2009Terminated |
| Z-0980-2009 | Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating…"Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for… | Vance Products Incorporated | 11/10/2008Terminated |
| Z-0853-2009 | Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0852-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0851-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0850-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0849-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0848-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0847-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0846-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0845-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0844-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0843-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0842-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0841-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0840-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-0839-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | Vance Products Incorporated | 07/31/2008Terminated |
| Z-2224-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | Applied Medical Resources Corp | 05/20/2008Terminated |
| Z-2223-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | Applied Medical Resources Corp | 05/20/2008Terminated |
| Z-2222-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | Applied Medical Resources Corp | 05/20/2008Terminated |
| Z-2221-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | Applied Medical Resources Corp | 05/20/2008Terminated |