Recall Register

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ev3 Inc

FDA recalling firm · 8 enforcement events · 11 product records · 2014–2024 · MN

ev3 Inc has 8 FDA enforcement events on this register (11 product records) between 2014 and 2024: 8 device; the busiest year was 2014 with 2.

25% of its events are Class I; the most common class is Class II (6). 1 event is listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
10 Dec 2024Medtronic 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: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X…DeviceClass II1Ongoing
4 Feb 2022Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.DeviceClass I2Terminated
6 Dec 2021Medtronic 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 intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for…DeviceClass I2Terminated
26 Aug 2020Pacific Xtreme (PTCA Balloon Dilation Catheter)DeviceClass II1Terminated
23 May 2016EV3 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 intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy…DeviceClass II1Terminated
29 Mar 2016ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.DeviceClass II1Terminated
4 Dec 2014ev3 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 revascularization and meet outlined criteria.DeviceClass II2Terminated
9 Apr 2014ev3 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 CatheterDeviceClass II1Terminated

By type and class

Device8
Class II6
Class I2

Class I: 25% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for ev3 Inc by year initiated.

Questions and answers

How many FDA recalls has ev3 Inc had?

8 enforcement events (11 product records) on this register, 2014–2024: 8 device.

Are any ev3 Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are ev3 Inc recalls?

6 Class II, 2 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.