Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
- Company
- Medtronic Inc
- Recall Initiated
- September 15, 2004
- Posted
- September 29, 2004
- Terminated
- November 3, 2005
- Recall Number
- Z-1489-04
- Quantity
- 753 units, 203 distributed in US to 24 customers.
- Firm Location
- Minneapolis, MN
Reason for Recall
Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
Distribution
Nationwide throughout the United States and worldwide.
Lot / Code Info
Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
Root Cause
Other
Action Taken
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.