Recall Z-0908-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
| Date | Mar 5, 2013 (initiated Feb 19, 2013) |
| Status | Terminated |
| Reason | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue. |
| Quantity | 13,691 (6711 USA; 6980 OUS) |
| Distribution | Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, |
| FDA record | Open on fda.gov |