Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 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 Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
Lot Codes / Batch Numbers
Lot number 5350420
Products Sold
Lot number 5350420
A medical device manufacturer is recalling Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 due to A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
Recommended Action
Per FDA guidance
Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots 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