Recall Z-1489-04 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Inc
Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
| Date | Sep 29, 2004 (initiated Sep 15, 2004) |
| Status | Terminated |
| Reason | Spiral tip from DLP VAD cannula may be loose and potentially detach during use. |
| Root cause | Other |
| Action | A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information. |
| Quantity | 753 units, 203 distributed in US to 24 customers. |
| Distribution | Nationwide throughout the United States and worldwide. |
| FDA record | Open on fda.gov |