Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and

FDA device recall Z-1408-2023 · posted 2023-04-19 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

Action taken

Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/17/2023 via UPS 2-day delivery. The notice explained the issue and the hazard and requested the following actions be taken: Quarantine all unused product from the affected lots and return them as described on the Customer Confirmation Form. Pass the notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

MHY

Quantity affected

1414 units

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands,

Date initiated

2023-03-17

Date posted

2023-04-19

Location

Minneapolis, MN