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Terminated

Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1

FDA Recall Z-0590-04 · Posted 2004-07-20

Recalling FirmStereotaxis Inc
Recall StatusTerminated
Product CodeNFN
Date Initiated2004-01-27
Date Terminated2005-10-31
Product Quantity76 guidewires

Reason for Recall

The magnet at the end of the guidewire could break off.

Firm Action

Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.

Root Cause

Other

Distribution Pattern

The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021363ENDOVASCULAR GUIDE WIREStereotaxis, Inc. · 2002-11-27

Official Source

View FDA Recall →

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

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