Recall Z-1552-2016— ev3, Inc.

Name: FDA recall Z-1552-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-29

Class II · Terminated

Class II FDA medical device recall by ev3, Inc., initiated 2016-03-29, terminated 2017-05-19. It names one FDA 510(k) clearance: K093286. Product: ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.. Reason: 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..

Recalling firm: ev3, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-29
Terminated: 2017-05-19
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K093286 — POWERCROSS .018 OTW PTA DILATION CATHETEREv3, Inc.·cleared 2009-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.