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Terminated

Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.

FDA Recall Z-0611-2007 · Posted 2007-03-16

Recalling FirmGuidant Cardiac Surgery
Recall StatusTerminated
Product CodeMWS
Date Initiated2006-12-01
Date Terminated2007-12-04
Product Quantity57,691 units distributed total

Reason for Recall

Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.

Firm Action

The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.

Root Cause

Other

Distribution Pattern

Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.

Official Source

View FDA Recall →

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

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