Medtronic InterStim Handset May Fail to Pair with Communicator
Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.
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 of a functional defect with no reported illnesses, injuries, or harm. The pairing failure prevents device setup but does not involve direct patient safety risk, consistent with a precautionary recall of a usability issue.
Plain-English summary
Medtronic Neuromodulation is recalling 211 units of the Handset with Communicator Model TH90Q01, part of the InterStim Smart Programmer and Communicator Kits, due to a pairing failure.
A subset of the affected handsets may not be able to complete the pairing process with the communicator upon initial setup. This functional defect prevents the communicator from being properly configured with the handset before use.
The recalled devices were distributed nationwide. Affected patients and healthcare providers should identify devices by checking serial numbers against FDA recall Z-3073-2024 and contact Medtronic for replacement units.
The recalled product
- Product
- Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 211
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 (20)
- GTIN 0076300092754
- serial numbers: NPV0082351
- NPV0085575
- NPV0082308
- NPV0082309
- NPV0082314
- NPV0082328
- NPV0082329
- NPV0082349
- NPV0082412
- NPV0082483
- NPV0082494
- NPV0082608
- NPV0082631
- NPV0082646
- NPV0082684
- NPV0082689
- NPV0082690
- NPV0082691
- NPV0082756
Distribution
Distributed nationwide across the United States.
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