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

Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906

FDA Recall Z-1034-03 · Posted 2003-07-19

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2003-06-23
Date Terminated2018-10-03
Product Quantity30 units

Reason for Recall

Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

Firm Action

Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.

Root Cause

Other

Distribution Pattern

Japan, Italy, France, Turkey, Israel, Finland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955293FIBERED PLATINUM COIL, .035 TYPETarget Therapeutics · 1996-02-06

Official Source

View FDA Recall →

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

↑