EV3, Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000059653 FEI 2183870
- Devices
- 1,099
- Registrations
- EUDAMEDFDA
- FDA recalls
- 911 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What EV3, Inc makes
EV3, Inc. manufactures peripheral vascular devices, including basic angioplasty balloon catheters, bare-metal peripheral artery stents, and manual vascular guidewires. Their portfolio also covers single-use vascular guide-catheters, intravascular extraction catheters with snare functionality, bare-metal biliary stents, and embolic protection filtering guidewires. Additional products include peripheral vascular guidewire extensions and specialized guidewires designed for protection during interventions.
The company’s devices are regulated under FDA Class II and Class III classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. EV3, Inc. is based in the United States.
Catalogue
Search and filter all 1,099 devicesShowing 1-50 of 1,099
Company details
- EUDAMED SRN
- US-MF-000059653
- FDA FEI number
- 2183870
- DUNS number
- 117446916
- EUDAMED status
- Active
- EUDAMED registered name
- eV3, Inc.
- Registered address
- 4600 Nathan Lane North, MN 55442, Plymouth, United States
- [email protected]
- Phone
- +1(800)633-8766
- PRRC contact
- Sharon Fahy
FDA recalls
FDA recall records list 91 recalls initiated by EV3, INC, the earliest on 2003-04-15 and the most recent on 2024-12-10. By recorded status: 1 ongoing and 90 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 2
- 2022 2
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 10 Dec 2024 Z-0904-2025 Class II Ongoing There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
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- 10 Dec 2024 Z-0904-2025 Class II Ongoing There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
2022
- 4 Feb 2022 Z-0694-2022 Class I Terminated 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.
- 4 Feb 2022 Z-0695-2022 Class I Terminated 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.
2021
- 6 Dec 2021 Z-0450-2022 Class I Terminated Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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- 6 Dec 2021 Z-0451-2022 Class I Terminated Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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- 6 Dec 2021 Z-0450-2022 Class I Terminated Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
2020
- 26 Aug 2020 Z-3055-2020 Class II Terminated Labeling discrepancy for the Rated Burst Pressure (RBP) value.
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- 26 Aug 2020 Z-3055-2020 Class II Terminated Labeling discrepancy for the Rated Burst Pressure (RBP) value.
2016
- 23 May 2016 Z-2048-2016 Class II Terminated 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 pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
- 29 Mar 2016 Z-1552-2016 Class II Terminated Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
2014
- 4 Dec 2014 Z-0878-2015 Class II Terminated 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.
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- 4 Dec 2014 Z-0879-2015 Class II Terminated 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.
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- 4 Dec 2014 Z-0878-2015 Class II Terminated 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.
Show the 25 most recent of 91 recalls
2014
- 9 Apr 2014 Z-1489-2014 Class II Terminated 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.
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- 9 Apr 2014 Z-1489-2014 Class II Terminated 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.
2010
- 12 Nov 2010 Z-0789-2011 Unclassified (pre-2012) Terminated 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.
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- 30 Oct 2010 Z-0626-2011 Unclassified (pre-2012) Terminated 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 Protg GPS stent but actually contai
- 31 Mar 2010 Z-1598-2010 Unclassified (pre-2012) Terminated 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.
- 21 Jan 2010 Z-1162-2010 Unclassified (pre-2012) Terminated 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.
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- 12 Nov 2010 Z-0789-2011 Unclassified (pre-2012) Terminated 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.
2009
- 6 Nov 2009 Z-0478-2010 Unclassified (pre-2012) Terminated 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.
- 6 Nov 2009 Z-0497-2010 Unclassified (pre-2012) Terminated 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.
- 10 Jun 2009 Z-2022-2009 Unclassified (pre-2012) Terminated 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 of the target lesion.
- 10 Jun 2009 Z-2023-2009 Unclassified (pre-2012) Terminated 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 of the target lesion.
- 10 Jun 2009 Z-2024-2009 Unclassified (pre-2012) Terminated 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 of the target lesion.
- 10 Jun 2009 Z-2025-2009 Unclassified (pre-2012) Terminated 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 of the target lesion.
2008
- 1 Jul 2008 Z-1547-2008 Unclassified (pre-2012) Terminated 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.
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- 1 Jul 2008 Z-1548-2008 Unclassified (pre-2012) Terminated 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.
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- 22 Apr 2008 Z-2169-2008 Unclassified (pre-2012) Terminated 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.
- 22 Apr 2008 Z-2170-2008 Unclassified (pre-2012) Terminated 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.
- 1 Jul 2008 Z-1547-2008 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does EV3, INC have in the registry?
The registry currently lists 1099 devices for EV3, INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list EV3, INC's devices?
Among its 50 most recently registered devices, EV3, INC has devices listed in EUDAMED (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EV3, INC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for EV3, INC's devices are Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for EV3, INC?
FDA recall records list 91 recalls initiated by EV3, INC, the most recent initiated on 10 Dec 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from EV3, INC in the registry?
The most recently registered devices listed for EV3, INC include EverFlex™, Liberant™ LMT-TRX, EverCross™ AB35W12060135 and EverFlex™ Protégé™ EverFlex™ PRB35-08-060-120.