Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
This recall has been terminated (originally issued March 29, 2016).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- February 9, 2016
- Posted
- March 29, 2016
- Terminated
- August 11, 2016
- Recall Number
- Z-1271-2016
- Quantity
- 9 (1 still unused)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.
Distribution
Internationally to Japan.
Lot / Code Info
N558983006
Root Cause
Under Investigation by firm
Action Taken
Medtronic sent an "Medical Device Removal" letter dated February 2016. The letter described the problem and the product involved in the recall. The Action Required was to segregate the unused affected product. Their Medtronic Representative will be contacting consignee. For questions contact your Medtronic representative, or call for further questions. (800) 707-0933