Medtronic Neuromodulation: Medical Device Recall in 2016 - (Recall #: Z-1271-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 9, 2016

Date Posted: April 6, 2016

Recall Number: Z-1271-2016

Event ID: 73426

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.

Status: Terminated

Product Quantity: 9 (1 still unused)

Code Information:

N558983006

Distribution Pattern:

Internationally to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated