Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical,...
FDA Device Recall #Z-2240-2026 - Class II, May 13, 2026
Recall Summary
| Recall Number | Z-2240-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 13, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Neuromodulation |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 275 units |
Product Description
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; 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.
Distribution Pattern
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Lot / Code Information
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.
Other Recalls from Medtronic Neuromodulation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2241-2026 | Class II | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain... | May 13, 2026 |
| Z-2201-2026 | Class II | Medtronic SynchroMed Flex Infusion Mode - A810 ... | Apr 8, 2026 |
| Z-1043-2026 | Class II | A71200 Vanta" Clinician Programmer Application ... | Dec 3, 2025 |
| Z-0996-2026 | Class II | Restore Clinician Programmer Application (CP Ap... | Nov 20, 2025 |
| Z-1704-2025 | Class II | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Apr 3, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.