ev3 Recalls
11 recalls on record · April 30, 2014 to January 22, 2025 · Medical Devices
Recalls by year
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16
20
22
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 22, 2025Medical DevicesFDA
ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) A
Hazard: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
March 16, 2022Medical DevicesFDA
ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral v
Hazard: 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.
March 16, 2022Medical DevicesFDA
ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral va
Hazard: 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.
January 26, 2022Medical DevicesFDA
ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommend
Hazard: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
January 26, 2022Medical DevicesFDA
ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommen
Hazard: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
October 7, 2020Medical DevicesFDA
ev3 Inc. recalls Pacific Xtreme (PTCA Balloon Dilation Catheter)
Hazard: Labeling discrepancy for the Rated Burst Pressure (RBP) value.
June 29, 2016Medical DevicesFDA
Ev3, Inc. recalls EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The
Hazard: 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.
May 4, 2016Medical DevicesFDA
ev3, Inc. recalls ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Hazard: 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.
January 7, 2015Medical DevicesFDA
Ev3, Inc. recalls ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of p
Hazard: 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.
January 7, 2015Medical DevicesFDA
Ev3, Inc. recalls ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of p
Hazard: 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.
April 30, 2014Medical DevicesFDA
Ev3, Inc. recalls ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035"
Hazard: 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.