ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Reported: May 4, 2016 Initiated: March 29, 2016 #Z-1552-2016
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.
Details
- Recalling Firm
- ev3, Inc.
- Units Affected
- 27 (25 US, 2 OUS)
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.. Recalled by ev3, Inc.. Units affected: 27 (25 US, 2 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1552-2016.
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