Medtronic Neurostimulators Recalled for Cycling Feature Labeling Concerns
Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling concern regarding device longevity claims without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Neuromodulation is recalling specific neurostimulator models, including the Restore, RestoreADVANCED, RestoreSENSOR, RestoreULTRA, Itrel 4, RestorePrime, and PrimeAdvanced series. These devices are used for pain and deep brain stimulation therapy. The recall involves 170,286 units in the United States and 73,921 units outside the United States.
The recall is initiated because the current labeling indicates that using the cycling feature improves device longevity and recharge interval. The cycling feature allows stimulation output to be toggled on and off based on programmed settings, a function determined by the physician and set using a clinician programmer. The source text does not specify reported injuries, illnesses, or deaths associated with this labeling issue.
Patients using these devices should contact their physician or Medtronic for further instructions regarding the recall and any necessary device adjustments or replacements.
The recalled product
- Product
- Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), It
- Manufacturer
- Medtronic Neuromodulation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- The first released affected product was released to the market in April
- 2005.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02