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Terminated

Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391221, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX

FDA Recall Z-1160-2007 · Posted 2007-08-09

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2007-06-04
Date Terminated2007-12-19
Product Quantity233

Reason for Recall

Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

Firm Action

Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.

Root Cause

Process control

Distribution Pattern

Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.

Official Source

View FDA Recall →

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

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