Z-2240-2026Class II

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted...

Name: Z-2240-2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted...
Creator: Medtronic Neuromodulation
Published: 2026-05-13
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2026-05-13 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor on 2026-05-13. FDA classified it as Class II and gives the reason as "A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2240-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-13
Posted: 2026-05-28
Recalling firm: Medtronic Neuromodulation
Product: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 275 units
Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Product codes and 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, Lot Number 0231367316; GTIN 00763000968441, Lot Number 0231367317; GTIN 00763000968441, Lot Number 0231367319; GTIN 00763000968441, Lot Number 0231367320; GTIN 00763000968441, Lot Number 0231367321; GTIN 00763000968441, Lot Number 0231367322; GTIN 00763000968441, Lot Number 0231514399; GTIN 00763000968441, Lot Number 0231514400; GTIN 00763000968441, Lot Number 0231514401; GTIN 00763000968441, Lot Number 0231514402; GTIN 00763000968441, Lot Number 0231514403; GTIN 00763000968441, Lot Number 0231514404; GTIN 00763000968441, Lot Number 0231514405; GTIN 00763000968441, Lot Number 0231514406; GTIN 00763000968441, Lot Number 0231514407; GTIN 00763000968441, Lot Number 0231514408; GTIN 00763000968441, Lot Number 0231514409; GTIN 00763000968441, Lot Number 0231514410; GTIN 00763000968441, Lot Number 0231514411; GTIN 00763000968441, Lot Number 0231514412; GTIN 00763000968441, Lot Number 0231514413; GTIN 00763000968441, Lot Number 0231929193; GTIN 00763000968441, Lot Number 0231929194; GTIN 00763000968441, Lot Number 0231929195; GTIN 00763000968441, Lot Number 0231929196; GTIN 00763000968441, Lot Number 0231929197; GTIN 00763000968441, Lot Number 0231929198; GTIN 00763000968441, Lot Number 0231929199; GTIN 00763000968441, Lot Number 0231929200; GTIN 00763000968441, Lot Number 0231929201; GTIN 00763000968441, Lot Number 0232153351; GTIN 00763000968441, Lot Number 0232153352; GTIN 00763000968441, Lot Number 0232153353; GTIN 00763000968441, Lot Number 0232153354; GTIN 00763000968441, Lot Number 0232153355; GTIN 00763000968441, Lot Number 0232153360; GTIN 00763000968441, Lot Number 0232212159; GTIN 00763000968441, Lot Number 0232212160; GTIN 00763000968441, Lot Number 0232212161; GTIN 00763000968441, Lot Number 0232224165; GTIN 00763000968441, Lot Number 0232224206; GTIN 00763000968441, Lot Number 0232224207; GTIN 00763000968441, Lot Number 0232224208; GTIN 00763000968441, Lot Number 0232224209; GTIN 00763000968441, Lot Number 0232224211; GTIN 00763000968441, Lot Number 0232224212; GTIN 00763000968441, Lot Number 0232224213; GTIN 00763000968441, Lot Number 0232224214; GTIN 00763000968441, Lot Number 0232224215; GTIN 00763000968441, Lot Number 0232224216; GTIN 00763000968441, Lot Number 0232224217; GTIN 00763000968441, Lot Number 0232224218; GTIN 00763000968441, Lot Number 0232546510; GTIN 00763000968441, Lot Number 0232546511; GTIN 00763000968441, Lot Number 0232554256; GTIN 00763000968441, Lot Number 0232554257; GTIN 00763000968441, Lot Number 0232589003; GTIN 00763000968441, Lot Number 0232589646; GTIN 00763000968441, Lot Number 0232589647; GTIN 00763000968441, Lot Number 0232589648; GTIN 00763000968441, Lot Number 0232589649; GTIN 00763000968441, Lot Number 0232589651; GTIN 00763000968441, Lot Number 0232676531; GTIN 00763000968441, Lot Number 0232676532; GTIN 00763000968441, Lot Number 0232676533; GTIN 00763000968441, Lot Number 0232676534; GTIN 00763000968441, Lot Number 0232676535; GTIN 00763000968441, Lot Number 0232676536; GTIN 00763000968441, Lot Number 0232676537; GTIN 00763000968441, Lot Number 0232676539; GTIN 00763000968441, Lot Number 0232676540; GTIN 00763000968441, Lot Number 0232676541; GTIN 00763000968441, Lot Number 0232725690; GTIN 00763000968441, Lot Number 0232725694; GTIN 00763000968441, Lot Number 0232725695; GTIN 00763000968441, Lot Number 0232725696; GTIN 00763000968441, Lot Number 0232725699.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2240-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2240-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2241-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)