Recall Z-1123-03 ยท MAF Stent, Coronary
Boston Scientific Scimed
Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
| Date | Aug 12, 2003 (initiated Jul 16, 2003) |
| Status | Terminated |
| Reason | There is an Increased potential for broken struts of the stents. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
| Quantity | 17 stent systems |
| Distribution | The products were shipped to consignees located nationwide 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.