Medtronic CareLink SmartSync RF Head Patient Connector Software Recall
Medtronic is recalling CareLink SmartSync RF Head Patient Connectors due to a software problem that may cause inaccurate displayed longevity estimates.
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 due to a software defect that may cause inaccurate displayed longevity estimates. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic, Inc. is recalling 11,741 units of the CareLink SmartSync, RF Head Patient Connector, Model 24967, which is a component for permanent, implantable pulse generators. The recall is due to a software problem that has the potential to result in an inaccurate displayed longevity estimate.
The affected units were distributed worldwide. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should contact Medtronic for instructions on how to address the software issue and ensure accurate longevity estimates are displayed.
The recalled product
- Product
- CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
- Manufacturer
- Medtronic, Inc.
- Affected units
- 11,741
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 00763000060435
- Serial Number RFA001598A
- Serial Number RFA001602A
- Serial Number RFA001786A
- Serial Number RFA001826A
- Serial Number RFA002016A
- Serial Number RFA002095A
- Serial Number RFA002591A
- Serial Number RFA003113A
- Serial Number RFA003146A
- Serial Number RFA003306A
- Serial Number RFA005031A
- Serial Number RFA005097A
- Serial Number RFA005103A
- Serial Number RFA008830A
- Serial Number RFA014171A
- Serial Number RFA014218A
- Serial Number RFA014252A
- Serial Number RFA014258A
- Serial Number RFA014278A
Distribution
Distribution scope not specified by the agency.
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