Recall Z-0776-03 ยท MAF Stent, Coronary
Boston Scientific Scimed
Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
| Date | Apr 22, 2003 (initiated Mar 17, 2003) |
| Status | Terminated |
| Reason | A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them. |
| Quantity | 1 Stent System |
| Distribution | 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.