Skip to content

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain… recallZ-2241-2026 · Medtronic Neuromodulation · initiated May 13, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/13/2026 via UPS 2 day mail. The notice described the issue and requested the following: Actions: " Identify and segregate affected products within your inventory. " Return all unused affected product(s) to Medtronic as described in the Consignee Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected product. " Share this notice with all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. " Complete and return the consignee confirmation form even if you do not have unused inventory. For questions regarding this communication, please contact your Medtronic Representative or Technical Services at 1-800-707-0933.

Recall details

Recall number
Z-2241-2026
Status
Open, Classified
Initiated by the company
May 13, 2026
Posted by the FDA
May 28, 2026
Recalling firm
Medtronic Neuromodulation
Quantity
31 units
Product code
MHY
FDA submissions
P960009
Distribution
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.

Product description

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

GTIN 00643169090866, Lot Number VA368G3; GTIN 00643169090866, Lot Number VA36V7T; GTIN 00643169936584, Lot Number VA3347Y; GTIN 00643169936584, Lot Number VA33481; GTIN 00643169936584, Lot Number VA33M8V; GTIN 00643169936584, Lot Number VA33M92; GTIN 00643169936584, Lot Number VA33T31; GTIN 00643169936584, Lot Number VA33T33; GTIN 00643169936584, Lot Number VA35B5D; GTIN 00643169936584, Lot Number VA35B5E; GTIN 00643169936584, Lot Number VA35WSP; GTIN 00643169936584, Lot Number VA35WSU; GTIN 00763000963040, Lot Number VA35TTU; GTIN 00763000963040, Lot Number VA35TTV; GTIN 00763000963040, Lot Number VA368FZ; GTIN 00763000963040, Lot Number VA368G3; GTIN 00763000963040, Lot Number VA36V7T; GTIN 00763000963040, Lot Number VA36V8Q; GTIN 00763000968427, Lot Number 0231980220; GTIN 00763000968427, Lot Number 0231980221; GTIN 00763000968427, Lot Number 0231980222; GTIN 00763000968434, Lot Number 0231493884; GTIN 00763000968434, Lot Number 0231493885; GTIN 00763000968434, Lot Number 0231494066; GTIN 00763000968434, Lot Number 0231928923; GTIN 00763000968434, Lot Number 0231929188; GTIN 00763000968434, Lot Number 0231929189; GTIN 00763000968434, Lot Number 0231929192; GTIN 00763000968441, Lot Number 0231367316; GTIN 00763000968441, Lot Number 0231367317.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

88 devices cleared under P960009 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98913).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page