Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400

FDA Recall Z-0776-03 · Posted 2003-04-22

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-03-17
Date Terminated2004-07-02
Product Quantity1 Stent System

Reason for Recall

A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide in the United States

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑