Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
FDA device recall Z-1061-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Maquet Inc
- Reason for recall
- Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 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.
- Date initiated
- 2005-05-20
- Date posted
- 2005-08-03
- Date terminated
- 2006-10-03
- Location
- East Bridgewater, NJ
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