Recall Z-1061-05 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Maquet Inc
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
| Date | Aug 3, 2005 (initiated May 20, 2005) |
| Status | Terminated |
| Reason | Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status. |
| Root cause | Other |
| Action | Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary. |
| Quantity | 890 units |
| Distribution | Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.