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

FDA device recall Z-1271-2016 · posted 2016-03-29 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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.

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

LKK

Quantity affected

9 (1 still unused)

Distribution

Internationally to Japan.

Date initiated

2016-02-09

Date posted

2016-03-29

Date terminated

2016-08-11

Location

Minneapolis, MN