Medtronic Intellis Recharger Recalled for Potential Unintended Heating
Medtronic is recalling 79,616 Intellis Model 97755 Rechargers worldwide due to a potential for unintended heating.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential heating) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling the Intellis Model 97755 Recharger. This device is designed to charge specific Medtronic rechargeable neurostimulators, including the Intellis with AdaptiveStim Technology Model 97715 and the Intellis Model 97716 Implanted Neurostimulators.
The recall is being conducted because there is a potential for unintended heating to occur with the recharger. The agency has classified this as a Class II recall. A total of 79,616 units were distributed worldwide, and the recall applies to all serial numbers.
Consumers who possess this device should stop using it and contact Medtronic Neuromodulation for instructions on how to proceed.
The recalled product
- Product
- Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 79,616
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 (1)
- All serial numbers
Distribution
Distribution scope not specified by the agency.
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