Z-1271-2016Class II

Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide

Name: Z-1271-2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide
Creator: Medtronic Neuromodulation
Published: 2016-02-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-02-09 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide on 2016-02-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1271-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-09
Posted: 2016-03-29
Terminated: 2016-08-11
Recalling firm: Medtronic Neuromodulation
Product: Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 9 (1 still unused)
Distribution: Internationally to Japan.
Product codes and lots: N558983006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1271-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1271-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-29

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)