Recall Z-1211-2007
Abbott Vascular-Cardiac Therapies dba Guidant Corporation · initiated July 16, 2007
Product
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
Codes / lots: Part number 1007848-15, lot number 7052951
Reason for recall
The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
FDA-determined cause: Other
Action taken
The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.
Details
- Recall number
- Z-1211-2007
- Initiated
- July 16, 2007
- Posted by FDA
- August 29, 2007
- Terminated
- June 14, 2011
- Product code
- MAF – Stent, Coronary
- Quantity
- 43 units
- Distribution
- Nationwide
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA