Data / Medical devices / United States / ev3, Inc.
ev3, Inc.: FDA-registered device maker in Plymouth, MN, United States, 71 510(k) clearances and 5 PMA approvals
ev3, Inc. is registered with the FDA (registration 2183870) in Plymouth, MN, United States. It lists 21 device types. The FDA files 71 510(k) clearances and 5 PMA approvals under its listings, the newest dated June 3, 2024. 40 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183870
- Address
- 4600 Nathan Lane North, Plymouth, MN, United States, 55442
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 8, 2007
- Registered through
- 2026
- Brand names listed
- "Micro Vascular Plug System (MVP) MVP Cable Sets MVP Detachment System ", Abre Venous Self-expanding Stent System, Admiral Xtreme, Admiral Xtreme PTA Balloon Catheter, Admiral Xtreme PTA Balloon Dilatation Catheter, Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon), Amphirion Deep 014" OTW PTA Balloon Catheter, Amphirion Deep 014" OTW PTA Balloon Catheter (Balloon Extension) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2024 | K241259 | Amplatz Goose Neck Snare Kit | MMX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 23, 2023 | K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 15, 2021 | K213631 | Chocolate PTA Balloon Catheter | LIT | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 24, 2021 | K212027 | TurboHawk Plus Directional Atherectomy System | MCW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202800 | Pacific Plus PTA Catheter | LIT | Substantially Equivalent | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | accessdata.fda.gov |
| January 10, 2020 | K192966 | FlowMet | DPW | Substantially Equivalent | Laser Associated Sciences, Inc. | accessdata.fda.gov |
| April 23, 2019 | K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | LIT | Substantially Equivalent | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | accessdata.fda.gov |
| April 12, 2018 | K173515 | Admiral Xtreme | LIT | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| June 16, 2017 | K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | MCW | Substantially Equivalent | Medtronic Vascular, Inc. | accessdata.fda.gov |
| October 14, 2016 | K161361 | HawkOne Directional Atherectomy System | MCW | Substantially Equivalent | Medtronic Vascular, Inc. | accessdata.fda.gov |
| September 22, 2016 | K162384 | TrailBlazer Angled Support Catheter | DQY | Substantially Equivalent | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | accessdata.fda.gov |
| April 22, 2015 | K150108 | Reverse Medical Micro Vascular Plug System | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| October 28, 2014 | K142654 | Fortrex 0.035 OTW PTA Balloon Catheter | LIT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 16, 2014 | K141801 | HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 5, 2014 | K141858 | CLOSURERFG RADIOFREQUENCY GENERATOR | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 18, 2014 | K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| June 18, 2014 | K141313 | REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| November 27, 2013 | K133282 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| September 26, 2013 | K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| July 2, 2013 | K123803 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| June 15, 2013 | K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 | LIT | Substantially Equivalent | Trireme Medical, Inc. | accessdata.fda.gov |
| May 24, 2013 | K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| January 29, 2013 | K123358 | PACIFIC PLUS | LIT | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 1, 2012 | K113289 | ORION MICRO CATHETER | KRA | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| July 13, 2012 | K121745 | MANTARAY GUIDEWIRES | DQX | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| May 22, 2012 | K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | PDU | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| April 19, 2012 | K120863 | WHOLEY GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 18, 2012 | K120881 | MANTARAY GUIDEWIRES | DQX | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| February 3, 2012 | K120129 | MANTARAY CATHETER | DQY | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| October 27, 2011 | K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | MCW | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| October 27, 2011 | K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| September 9, 2011 | K111887 | CLOSUREFAST RADIOFREQUENCY CATHETER | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 30, 2011 | K111488 | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 | DQX | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| April 14, 2011 | K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| January 5, 2011 | K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | MCW | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| December 6, 2010 | K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| April 30, 2010 | K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Invatec S.P.A. | accessdata.fda.gov |
| November 13, 2009 | K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER | LIT | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| November 6, 2009 | K093301 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | MCW | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| October 15, 2009 | K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 | NTE | Substantially Equivalent | Invatec S.P.A. | accessdata.fda.gov |
| August 7, 2009 | K092299 | TRAILBLAZER SUPPORT CATHETER | DQY | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| March 13, 2009 | K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies, S.R.L. | accessdata.fda.gov |
| December 4, 2008 | K082854 | NANOCORSS .014 OTW PTA DILATATION CATHETER | DQY | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| March 18, 2008 | K072301 | 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 | FGE | Unknown | Ev3, Inc. | accessdata.fda.gov |
| February 12, 2008 | K071432 | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE | MCW | Substantially Equivalent | Fox Hollow Technologies | accessdata.fda.gov |
| November 9, 2007 | K071826 | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 | QEZ | Substantially Equivalent | Fox Hollow Technologies | accessdata.fda.gov |
| January 19, 2007 | K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | NFA | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| November 14, 2006 | K063204 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| October 23, 2006 | K061188 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | MCW | Substantially Equivalent | Foxhollow Technologies, Inc. | accessdata.fda.gov |
| October 18, 2006 | K062809 | ADMIRAL XTREME PTA CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies | accessdata.fda.gov |
| August 31, 2006 | K061566 | PRIMUS GPS BILIARY STENT SYSTEM | FGE | Unknown | Ev3, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| March 8, 2006 | K060057 | PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM | FGE | Unknown | Ev3, Inc. | accessdata.fda.gov |
| January 13, 2006 | K053460 | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, | MCW | Substantially Equivalent | Fox Hollow Technologies | accessdata.fda.gov |
| November 4, 2005 | K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies, S.R.L. | accessdata.fda.gov |
| October 11, 2005 | K052003 | VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| April 20, 2005 | K050725 | PROTEGE GPS SELF-EXPANDING NITINOL STENT | FGE | Substantially Equivalent | Ev3 Corporation | accessdata.fda.gov |
| February 18, 2005 | K043553 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 | MCW | Substantially Equivalent | Fox Hollow Technologies | accessdata.fda.gov |
| February 11, 2005 | K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies, S.R.L. | accessdata.fda.gov |
| January 10, 2005 | K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies, S.R.L. | accessdata.fda.gov |
| June 7, 2004 | K040638 | VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| March 2, 2004 | K040345 | MODIFICATION TO NITREX NITINOL GUIDEWIRE | DQX | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| November 21, 2003 | K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM | FGE | Unknown | Ev3, Inc. | accessdata.fda.gov |
| October 22, 2003 | K032580 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM | FGE | Unknown | Ev3, Inc. | accessdata.fda.gov |
| April 16, 2002 | K020528 | INTRASTENT LD (LARGE DIAMETER) STENT | FGE | Unknown | Sulzer Intratherapeutics, Inc. | accessdata.fda.gov |
| March 1, 2000 | K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| February 1, 2000 | K993904 | INTRASTENT DOUBLESTRUT LD | FGE | Unknown | Intratherapeutics, Inc. | accessdata.fda.gov |
| June 10, 1998 | K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE | DQY | Substantially Equivalent | Microvena Corp. | accessdata.fda.gov |
| March 6, 1998 | K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | DXE | Substantially Equivalent | Microvena Corp. | accessdata.fda.gov |
| November 8, 1991 | K914046 | THE BIG EASY Y-ADAPTER | DYB | Substantially Equivalent | Microvena Corp. | accessdata.fda.gov |
| May 23, 1990 | K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | DQX | Substantially Equivalent | Flexmedics | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 21, 2020 | P200026 | Abre Venous Self-expanding Stent System | QAN | 19 | October 16, 2026 | accessdata.fda.gov |
| February 20, 2015 | P140018 | VENASEAL CLOSURE SYSTEM | PJQ | 47 | October 15, 2026 | accessdata.fda.gov |
| March 7, 2012 | P110023 | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) | NIP | 66 | October 16, 2026 | accessdata.fda.gov |
| January 24, 2007 | P060001 | PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS | NIM | 56 | October 16, 2026 | accessdata.fda.gov |
| June 8, 2004 | P030045 | INTRASTENT DOUBLESTRUT STENT | NIO | 10 | October 16, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 4, 2025 | 98157 | Class II | Ongoing | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090 | Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. | accessdata.fda.gov |
| December 10, 2024 | 96006 | Class II | Ongoing | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. | accessdata.fda.gov |
| February 16, 2024 | 94167 | Class II | Ongoing | Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 | There is a potential for sterile package breach. | accessdata.fda.gov |
| November 20, 2023 | 93558 | Class II | Completed | Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. | Seal defects could compromise the ability of the product packaging to maintain sterility. | accessdata.fda.gov |
| July 14, 2022 | 90652 | Class II | Ongoing | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System | Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. | accessdata.fda.gov |
| February 4, 2022 | 89470 | Class I | Terminated | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature. | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. | accessdata.fda.gov |
| December 6, 2021 | 89229 | Class I | Terminated | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is int | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. | accessdata.fda.gov |
| March 23, 2021 | 87619 | Class III | Terminated | VenaSeal Closure System | Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. | accessdata.fda.gov |
| March 16, 2021 | 87638 | Class II | Terminated | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. | Incorrect size printed on the device; packaging is labeled correctly. | accessdata.fda.gov |
| August 26, 2020 | 86393 | Class II | Terminated | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | accessdata.fda.gov |
| November 3, 2017 | 78570 | Class II | Terminated | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Fe | Stent length on the label may not match the length of the stent itself. | accessdata.fda.gov |
| May 23, 2016 | 74276 | Class II | Terminated | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system inte | Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner p | accessdata.fda.gov |
| December 4, 2014 | 69965 | Class II | Terminated | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid rev | Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error. | accessdata.fda.gov |
| April 9, 2014 | 68034 | Class II | Terminated | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. | accessdata.fda.gov |
| November 12, 2010 | 57335 | Not yet classified | Terminated | ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030080150, AB14W035120150 | ev3 has determined that specific lots of the NanoCross.014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in material separation and potential embolization. | accessdata.fda.gov |
| October 30, 2010 | 57112 | Not yet classified | Terminated | ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Bi | Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Pro | accessdata.fda.gov |
| March 31, 2010 | 55303 | Not yet classified | Terminated | ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plym | ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent. | accessdata.fda.gov |
| January 21, 2010 | 52299 | Not yet classified | Terminated | SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, I | ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging. | accessdata.fda.gov |
| November 6, 2009 | 53879 | Not yet classified | Terminated | TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-03 | Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization. | accessdata.fda.gov |
| November 6, 2009 | 53867 | Not yet classified | Terminated | Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Se | ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention. | accessdata.fda.gov |
| June 10, 2009 | 52642 | Not yet classified | Terminated | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outsi | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage | accessdata.fda.gov |
| July 1, 2008 | 49366 | Not yet classified | Terminated | ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080,PXB35-07-57-080, PXB35-08-1 | ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. | accessdata.fda.gov |
| April 22, 2008 | 48615 | Not yet classified | Terminated | Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7,.40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neopla | A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent. | accessdata.fda.gov |
| April 22, 2008 | 48614 | Not yet classified | Terminated | Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm,.35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatm | A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent. | accessdata.fda.gov |
| April 9, 2008 | 48102 | Not yet classified | Terminated | ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07. | An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent. | accessdata.fda.gov |
| April 2, 2008 | 48098 | Not yet classified | Terminated | ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has bee | Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135). | accessdata.fda.gov |
| January 18, 2008 | 46693 | Not yet classified | Terminated | ev3 IntraStent Biliary Stent, Model Number: S10-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001. | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | accessdata.fda.gov |
| May 18, 2007 | 38052 | Not yet classified | Terminated | Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snar | Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. | accessdata.fda.gov |
| December 6, 2006 | 37006 | Not yet classified | Terminated | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. | Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected. | accessdata.fda.gov |
| March 8, 2006 | 34884 | Not yet classified | Terminated | ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. | A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter. | accessdata.fda.gov |
| February 27, 2006 | 34858 | Not yet classified | Terminated | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (N | Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected. | accessdata.fda.gov |
| February 14, 2006 | 34708 | Not yet classified | Terminated | X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, | Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to | accessdata.fda.gov |
| December 29, 2005 | 34357 | Not yet classified | Terminated | IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is inten | IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001) | accessdata.fda.gov |
| August 16, 2005 | 34337 | Not yet classified | Terminated | Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x.018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA | ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled. | accessdata.fda.gov |
| August 1, 2005 | 34352 | Not yet classified | Terminated | Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75 | A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent. | accessdata.fda.gov |
| June 10, 2005 | 32459 | Not yet classified | Terminated | ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | accessdata.fda.gov |
| September 1, 2004 | 29996 | Not yet classified | Terminated | Biliary Stent System (6Fr 9mm x 30mm). | A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device | accessdata.fda.gov |
| July 9, 2004 | 29629 | Not yet classified | Terminated | Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary) | Ev3 had received customer complaints indicating that the stent device could not be used with an.035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018'). | accessdata.fda.gov |
| January 29, 2004 | 28210 | Not yet classified | Terminated | ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm.018'" REF PMB 8-7-21-80 | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | accessdata.fda.gov |
| April 15, 2003 | 26093 | Not yet classified | Terminated | Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 | The label had an expiration date of August 2005, but the correct expiration date was February 2005. | accessdata.fda.gov |
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Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.