ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
FDA device recall Z-1552-2016 · posted 2016-04-22 · Terminated
Recall details
- Recalling firm
- ev3, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 27 (25 US, 2 OUS)
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Date initiated
- 2016-03-29
- Date posted
- 2016-04-22
- Date terminated
- 2017-05-19
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWERCROSS .018 OTW PTA DILATION CATHETER (K093286) | Ev3, Inc. | 2009-11-13 |