Device product
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Z-1552-2016
Product summary
- Firm
- ev3, Inc.
- Event
- Event 73706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 (25 US, 2 OUS)
- Official record key
device-enforcement:Z-1552-2016
Official wording
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.
Code information: A213373 and A216702
Distribution pattern: US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Derived failure modes
-
Labeling or packaging
mislabeled