Medtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
Medtronic is recalling InterStim Percutaneous Extensions because selecting an incompatible lead or extension may prevent the system from working as intended, potentially delaying surgery or requiring replacement.
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 is classified as FDA Class II, and the source describes a hazard where an incompatible lead prevents the system from working, potentially delaying surgery or requiring replacement. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic Neuromodulation is recalling InterStim Percutaneous Extensions (catalog numbers 3560022 and 3560030) due to a risk of selecting the wrong lead or percutaneous extension. The recall covers 56,331 units in the United States and 40,211 units outside the US, distributed worldwide to numerous countries including Brazil, Canada, Japan, and the United Kingdom.
The hazard identified is that using an incompatible lead or percutaneous extension will prevent the InterStim system from working as intended. This malfunction may result in a delay of surgery or the need for surgical replacement of the product. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should contact Medtronic Neuromodulation for instructions on how to proceed with affected devices. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
The recalled product
- Product
- InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neuromodulation
Distribution
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