Recall Z-0454-05 ยท DQY Catheter, Percutaneous
Boston Scientific Scimed
RunWay 6F Cardiovascular Guide Catheter.
| Date | Jan 28, 2005 (initiated Oct 29, 2004) |
| Status | Terminated |
| Reason | The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon |
| Root cause | Other |
| Action | On 10/29/04 the Boston Scientific Sales force was notified via voice mail of the recall. Sales personnel were told to contact their accounts/customers by the end of the business day on 11/02/04. Accounts/customers were to receive written notice of the recall via Fed Ex on Monday 11/01/04. Sales Personnel are to ensure that accounts/customers got notice of the recall, understand instructions and are taking appropriate steps. Catheters are to be returned to Boston Scientific Corporation, Quincy, MA. |
| Quantity | 76,984 |
| Distribution | Throughout United States and into 15 other countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033441 | BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER Boston Scientific Corp, Nov 21, 2003 |