Recall Z-0390-2019 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
| Date | Sep 5, 2018 |
| Status | Terminated |
| Reason | Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). |
| Root cause | Process control |
| Action | A letter dated September 5, 2018 was sent to all their customers by Cordis with the following request: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. 4) Return any affected product to the addres |
| Quantity | 162 units total (74 units in USA) |
| Distribution | Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corporation, Jun 14, 2012 |