Z-1408-2023Class II

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

Name: Z-1408-2023 Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the...
Creator: Medtronic Neuromodulation
Published: 2023-03-17
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-03-17 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain... on 2023-03-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1408-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-17
Posted: 2023-04-19
Recalling firm: Medtronic Neuromodulation
Product: Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.
Product codes and lots: UDI/DI00763000426361, Serial Numbers: HG56BR6, HG56C4R, HG56CJAH01, HG56CLE, HG586N7, HG586UM, HG58704, HG58VM0, HG58VQH, HG58VQHH01, HG58VY5, HG58W7H, HG58WWC, HG58WYB, HG58WYBH01, HG58X0E, HG597BH, HG597DH, HG597M8, HG59ABH, HG59AFC, HG59AV6, HG59RY0, HG5A9GT, HG5A9VY, HG5A9VZ, HG5AQH0, HG5AQQE, HG5BQ5Y, HG5BQLR, HG5BQPJ, HG5BTW7, HG5BTZX, HG5BU5W, HG5BU77, HG5EPSB, HG5EQ0C, HG5EQ2A, HG5EQ69, HG5F31N, HG5F338, HG5F3AZ, HG5F3EH, HG5F3G6, HG5F3K5, HG5F3NF, HG5FP0Y, HG5FP3B, HG5FP70, HG5FP70H01, HG5FPBE, HG5HQBM, HG5HQF8, HG5LJTL, HG5LJZQ, HG5LK2J, HG5LK4H, HG5LK5Y, HG5LK7C, HG5LK8P, HG5LK92, HG5LKAL, HG5LKC9, HG5LKEL, HG5LKGT, HG5LR02, HG5LR33, HG5LTWA, HG5LTWP, HG5LTXU, HG5LTYY, HG5LU12; UDI/DI 00763000486518, Serial Numbers: HG59ABH, HG59RY0, HG59SJ4, HG59SNC, HG5A9H3, HG5A9NB, HG5A9VY, HG5BQ5Y, HG5BQAW, HG5BQLR.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1408-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1408-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19

Product code MHY

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)