Recall Z-0892-2017 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Medtronic Inc
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral
| Date | Dec 22, 2016 (initiated Nov 10, 2016) |
| Status | Terminated |
| Reason | Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion. |
| Root cause | Process control |
| Action | Medtronic verbally communicated about the issue on November 20. 2016, to affected customers. Additionally, consignees were hand delivered by Field Sales Representatives a Medtronic "Urgent Medical Device Recall" letter dated November 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to immediately identify, quarantine the affected product, and return it to Medtronic. Requested consignees to complete and email the Customer Confirmation Certificate to RS.CFQFCA@medtronic.com o |
| Quantity | 315 |
| Distribution | NY, NC, WA |
| 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 |