Recall Z-0729-04 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Scimed
Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
| Date | Jul 20, 2004 (initiated Feb 13, 2004) |
| Status | Terminated |
| Reason | Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them. |
| Quantity | 11 catheters |
| Distribution | The product was shipped to consignees in Florida in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.