Recalls / —
—#144178
Product
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P860004
- Affected lot / code info
- N558983006
Why it was recalled
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- Internationally to Japan.
Timeline
- Recall initiated
- 2016-02-09
- Posted by FDA
- 2016-03-29
- Terminated
- 2016-08-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144178. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.