Recall Z-1141-03 ยท MAF Stent, Coronary
Abbott Vascular Devices
BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.
| Date | Aug 20, 2003 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage. |
| Root cause | Other |
| Action | On 7/21/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall. |
| Distribution | Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.