Medtronic recalls SenSight Extension Tunneler Kit REF B31030 with dual carriers machined on one side, preventing simultaneous extension passage. Affected units have specific serial numbers and UDI/DI codes.
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.
Medtronic is recalling SenSight Extension Tunneler Kits that have dual carriers machined on only one side. This defect means the kit cannot be used to pass two extensions at the same time, which could lead to improper surgical procedures.
The dual carrier in the kit is designed to pass two extensions simultaneously during surgery. If only one side is machined, the carrier cannot function properly, potentially causing surgical complications.
Patients using deep brain stimulation implants may be affected. Medical professionals who use these kits for surgical procedures are most at risk.
Check for the UDI/DI code 00763000426361 or the specific serial numbers listed in the recall notice. The kit is used for deep brain stimulation surgery.
Compare your kit's serial numbers with the list provided in the recall notice to determine if it is affected.
Medtronic has received reports that the dual carriers in these kits were machined on only one side, preventing the kit from passing two extensions simultaneously during surgery.
Check your kit's serial numbers against the list provided in the recall notice to see if it is affected. If affected, contact Medtronic for further instructions.
The recall indicates a potential for surgical complications, but the hazard is described as a functional issue rather than a direct risk of serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1408-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1408-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
