Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
FDA device recall Z-0612-2007 · posted 2007-03-16 · Terminated
Recall details
- Recalling firm
- Guidant Cardiac Surgery
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MWS
- Quantity affected
- 57,691 units distributed total
- Distribution
- Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
- Date initiated
- 2006-12-01
- Date posted
- 2007-03-16
- Date terminated
- 2007-12-04
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.