Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
FDA device recall Z-1123-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- There is an Increased potential for broken struts of the stents.
- Action taken
- Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 17 stent systems
- Distribution
- The products were shipped to consignees located nationwide in the United States.
- Date initiated
- 2003-07-16
- Date posted
- 2003-08-12
- Date terminated
- 2006-12-28
- Location
- Maple Grove, MN
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