Medtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
Medtronic is recalling InterStim SureScan MRI Leads because selecting an incompatible lead or extension prevents the system from working as intended.
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 Class II because the use of an incompatible lead or extension prevents the system from working as intended, potentially causing surgery delays or the need for replacement. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic Neuromodulation is recalling InterStim SureScan MRI Leads 978A1 and 978B1. The recall involves specific lead models and lots distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is due to the potential for the wrong lead or percutaneous extension to be selected. Using an incompatible lead or percutaneous extension will prevent the InterStim system from working as intended. This issue 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. Consumers and healthcare providers should contact Medtronic Neuromodulation for instructions on how to proceed with the recall.
The recalled product
- Product
- InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II…
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neuromodulation
Distribution
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