Recall Z-1121-04 ยท MAF Stent, Coronary
Boston Scientific Corporation
Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.
| Date | Jul 27, 2004 (initiated Jul 16, 2004) |
| Status | Terminated |
| Reason | Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. |
| Root cause | Other |
| Action | Press release has been issued. Institutions with affected units will receive packages outlining the recall process and should immediately discontinue use of these units. Clinician and patient inquiries may be directed to Boston Scientific. |
| Quantity | 82,424 |
| Distribution | Inside U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.