Recall Z-1052-04 ยท NIQ Coronary Drug-Eluting Stent
Boston Scientific Scimed
TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897
| Date | Jul 20, 2004 (initiated Jul 1, 2004) |
| Status | Terminated |
| Reason | On a few occasions the balloon has failed to deflate within one minute after deployment of the stent. |
| Root cause | Other |
| Action | July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason. |
| Quantity | 205,983 units plus additional 3,000 units recalled on 8/5/04. |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.