Medtronic Neurostimulator Recall Due to Inaccurate Battery Longevity Estimates
Medtronic is recalling specific neurostimulator models because enabling cycling at certain settings may decrease battery life and cause inaccurate longevity estimates on the programmer.
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: The recall addresses a labeling and software accuracy issue regarding battery longevity estimates without reported injuries or deaths, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic Neuromodulation is recalling specific neurostimulator models, including the Quadripolar ITREL 3 IPG (Model 7425), InterStim II Neurostimulator (Model 3058), InterStim Neurostimulator (Model 3023), and Enterra Neurostimulator (Model 3116). The recall affects 396,975 units distributed worldwide, including the United States, Mexico, and Canada.
The recall is issued because current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may actually decrease the device's battery longevity. Additionally, when cycling is enabled, the longevity estimate displayed on the Model 8840 Programmer may be inaccurate.
Patients using these devices should contact their healthcare provider or Medtronic for instructions on how to manage their device settings and monitor battery status to ensure safe and effective therapy.
The recalled product
- Product
- The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator…
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neurostimulator
Distribution
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