Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation recall (Medtronic Neuromodulation)
Medical deviceClass IIOngoing
Summary: Medtronic Neuromodulation is recalling Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor. Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
What is being recalled
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Why
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2241-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 13, 2026 |
| Reported | June 3, 2026 |
| Company | Medtronic Neuromodulation |
| Company location | Minneapolis, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 31 units |
More recalls from Medtronic Neuromodulation · all medical device recalls · recalls from May 2026