Medtronic InterStim Ground Pad Recalled for Incorrect Expiration Date Label
Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall involving a labeling defect—an incorrect expiration date on product packaging. No injuries, illnesses, or hospitalizations have been reported. The hazard is primarily a documentation/labeling issue rather than a use-safety defect, placing it in the minor-labeling-error category per the rubric.
Plain-English summary
Medtronic Neuromodulation is recalling the InterStim Self-Adhesive Ground Pad (Product Number 041826, Lot 60347246) because the product is labeled with an incorrect expiration date. This labeling error prevents users from reliably determining the device's actual shelf-life status.
The recalled product consists of 360 packs (36 kits of 10 packs each) and was distributed internationally to Iran. InterStim ground pads are components used in neuromodulation therapy systems.
Consumers and healthcare providers who have received this product should verify the actual expiration date with Medtronic before use. No injuries or illnesses have been reported.
The recalled product
- Product
- Medtronic InterStim Ground Pad REF 041826
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neuromodulation
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 (3)
- Product Number: 041826
- UDI: 20763000343273
- Lot Number: 60347246
Distribution
Distribution scope not specified by the agency.
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