Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
Lot Codes / Batch Numbers
Lot number 5140999
Products Sold
Lot number 5140999
A medical device manufacturer is recalling Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H74935 due to The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
Recommended Action
Per FDA guidance
Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot 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