Recall Z-2241-2026

Medtronic Neuromodulation · initiated May 13, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: 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…

Reason for recall

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

FDA-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-2241-2026
Initiated
May 13, 2026
Posted by FDA
May 28, 2026
Product code
MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Quantity
31 units
Distribution
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Recalling firm
Medtronic Neuromodulation, Minneapolis, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2240-2026 Class IIMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator…A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. 05/13/2026Open, Classified