Class II Recall

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

Summary

The FDA issued a Class II for Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimul by Medtronic Neuromodulation. Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates..

Details

Source

Device Recall

External ID

Z-2240-2026

Action Date

2026-06-03

Status

Ongoing

Product Description

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

Lot/Code Info: 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.

Quantity Affected: 275 units

Reason for Recall

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

Distribution

Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-13

Company

Medtronic Neuromodulation

Minneapolis, MN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 129 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medtronic Neuromodulation have FDA actions?

Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2240-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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