Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
Lot Codes / Batch Numbers
Lot 5570485
Products Sold
Lot 5570485
A medical device manufacturer is recalling Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35 due to There is an Increased potential for broken struts of the stents.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is an Increased potential for broken struts of the stents.
Recommended Action
Per FDA guidance
Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026