Recall Z-2235-2021 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
| Date | Jul 19, 2021 |
| Status | Terminated |
| Reason | The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices. |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER Cordis Corporation, Jun 27, 2014 |