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Terminated

POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

FDA Recall Z-1805-2009 · Posted 2009-07-29

Recalling FirmAbbott Vascular-Cardiac Therapies dba Guidant Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2009-06-17
Date Terminated2010-07-06
Product Quantity557 total devices

Reason for Recall

Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

Firm Action

Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.

Root Cause

Process control

Distribution Pattern

Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.

Official Source

View FDA Recall →

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

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