ev3 recalls

ev3 has 11 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 22 Jan 2025. 1 is still ongoing.

Total recalls11since 2014

Last 12 months0reported

Class I436% of total

Ongoing1latest 22 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 4 36%Class II 7 64%Class III 0 0%

Why ev3 is recalled

Other Reasons655%
Labeling Errors545%

Product types

Heart & Vascular Devices982%
Other Medical Devices218%

By year

202519%
2022436%
202019%
2016218%
2015218%
201419%

Ongoing ev3 recalls

1 active

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Medtronic NanoCross Elite PTA catheter recalled by ev3	ev3	Other	Nationwide

All ev3 recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Medtronic NanoCross Elite PTA catheter recalled by ev3	ev3	Other	Nationwide
16 Mar 2022Device	CLASS I	Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled	ev3	Other	Nationwide
16 Mar 2022Device	CLASS I	Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled	ev3	Other	Nationwide
26 Jan 2022Device	CLASS I	Medtronic HawkOne Directional Atherectomy System recalled by ev3	ev3	Other	Nationwide
26 Jan 2022Device	CLASS I	Medtronic HawkOne Directional Atherectomy System recalled by ev3	ev3	Other	Nationwide
7 Oct 2020Device	CLASS II	Pacific Xtreme (PTCA Balloon Dilation Catheter) recalled by ev3	ev3	Other	42 states
29 Jun 2016Device	CLASS II	EverFiex" Self-expanding Peripheral Stent System recalled by Ev3	Ev3	Labeling Errors	Nationwide
4 May 2016Device	CLASS II	PowerCross" 0.018" OTW PTA Dilatation Catheter recalled by ev3	ev3	Labeling Errors	13 states
7 Jan 2015Device	CLASS II	Protege Rx Tapered Carotid Stent System, Secx-10 recalled by Ev3	Ev3	Labeling Errors	MN
7 Jan 2015Device	CLASS II	Prot¿g¿ Rx Tapered Carotid Stent System, Sepx-8 recalled by Ev3	Ev3	Labeling Errors	MN
30 Apr 2014Device	CLASS II	EverCross 0.035" OTW PTA Dilatation Catheter recalled by Ev3	Ev3	Labeling Errors	6 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.