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Terminated

Voyager RX Coronary Dilatation Catheter

FDA Recall Z-0707-05 · Posted 2005-04-13

Recalling FirmGuidant Corporation Advanced CardiovascularSystem
Recall StatusTerminated
Product CodeMAF
Date Initiated2005-01-27
Date Terminated2012-03-29
Product Quantity180,000 units

Reason for Recall

Leak at guide wire exit notch could introduce air into the artery.

Firm Action

Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.

Root Cause

Other

Distribution Pattern

Worldwide. Direct to customers in: Austria, Belgium & Luxumburg, Canada, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, The UK. To Distributors in: Finland, Iceland, Ireland, Lithuania, Barhain, Bulgaria, Cypres, Greece, Hungary, Israel, Jordan, Kuwait, Lebanon, Morocco, Poland, Russia, Saudi Arabia, South Africa, Syria, Tunisia, Turkey, UAE. Also countries in South and Central America although specifics are not known as above. Firm communicated with Competent Authorities in the 30 countries listed above.

Official Source

View FDA Recall →

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

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