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Terminated

Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.

FDA Recall Z-1396-05 · Posted 2005-08-24

Recalling FirmGuidant Cardiac Surgery
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-07-05
Date Terminated2006-01-09
Product Quantity7391 units

Reason for Recall

Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device

Firm Action

Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented.

Root Cause

Other

Distribution Pattern

Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.

Official Source

View FDA Recall →

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

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