CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

PowerCross" 0.018" OTW PTA Dilatation Catheter recalled by ev3

ev3 is recalling PowerCross" 0.018" OTW PTA Dilatation Catheter, distributed in 13 states. The recall was initiated on 29 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA213373 and A216702

Quantity recalled27 (25 US, 2 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1552-2016
FDA event ID: 73706
Recalling firm: ev3, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2016
FDA classified: 22 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

29 Mar 2016	Recall initiated by company
22 Apr 2016	Classified by FDA	+24 days
4 May 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

Where it was distributed

US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE

California Georgia Louisiana Michigan Missouri Mississippi New Hampshire Nevada New York Ohio Pennsylvania South Dakota Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

A213373 and A216702

Where was it sold?

US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ev3

All 11

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

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide