PlainRecordsFDA · Medical device recall
Boston Scientific Scimed Monorail Express 2 Coronary Stent System…
- Date posted by the FDA
- Aug. 12, 2003
- Status
- Terminated
- Filed by
- Boston Scientific Scimed
- Product
- Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
- Reason
- There is an Increased potential for broken struts of the stents.
- Distribution pattern
- The products were shipped to consignees located nationwide in the United States.
- Quantity
- 17 stent systems
- Codes and lots
- Lot 5570485
- Recall started
- July 16, 2003
- Device type
- Stent, Coronary
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
- Recall number
- Z-1123-03
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-1123-03. The agency record governs; check it and the company before acting.