Recall Z-0250-2020 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
| Date | Oct 4, 2019 |
| Status | Terminated |
| Reason | Product was manufactured utilizing an expired inner body. |
| Root cause | Process control |
| Action | Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set as |
| Quantity | 21 units |
| Distribution | US distribution to AL, AZ, FL, MN, and MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991811 | CORDIS MAXI DS PTA BALLOON CATHETER Cordis Corp., Jun 15, 1999 |