Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx… recallZ-1271-2016 · Medtronic Neuromodulation · initiated Feb 9, 2016
Class II Terminated All recalls posted in March 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1271-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 9, 2016
- Posted by the FDA
- Mar 29, 2016
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 9 (1 still unused)
- Product code
- LKK
- FDA submissions
- P860004
- Distribution
- Internationally to Japan.
Product description
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Code information (models, lots, serial numbers)
N558983006
Other devices under the same FDA submission
51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED™ III 8667-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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