Recall Z-0611-2007 ยท MWS Stabilizer, Heart
Guidant Cardiac Surgery
Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
| Date | Mar 16, 2007 (initiated Dec 1, 2006) |
| Status | Terminated |
| Reason | Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery. |
| Root cause | Other |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.