Recall Z-1552-2016 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ev3, Inc.
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
| Date | Apr 22, 2016 (initiated Mar 29, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall. |
| Quantity | 27 (25 US, 2 OUS) |
| Distribution | US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER Ev3, Inc., Nov 13, 2009 |