Medtronic CareLink SmartSync Programmer Recalled for Inaccurate Longevity Estimates
Medtronic is recalling CareLink SmartSync Programmer units due to a software problem that may cause inaccurate displayed longevity estimates for implanted pulse generators.
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, and the hazard is a software problem causing inaccurate displayed longevity estimates. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic, Inc. is recalling the CareLink SmartSync Programmer, Model 24970A, a device used with permanent, implantable pulse generators. The recall involves 11,238 units that were distributed worldwide.
The recall is being conducted because of a software problem that has the potential for an inaccurate displayed longevity estimate. This issue affects the information displayed to users regarding the remaining life of the implanted device.
The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it report any illnesses, injuries, or deaths associated with this software issue.
The recalled product
- Product
- CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
- Manufacturer
- Medtronic, Inc.
- Affected units
- 11,238
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 00763000044688
- Serial Number SPM001252A
- Serial Number SPM001274A
- Serial Number SPM001303A
- Serial Number SPM001309A
- Serial Number SPM001317A
- Serial Number SPM001321A
- Serial Number SPM001323A
- Serial Number SPM001332A
- Serial Number SPM001375A
- Serial Number SPM001505A
- Serial Number SPM001554A
- Serial Number SPM001565A
- Serial Number SPM001576A
- Serial Number SPM001582A
- Serial Number SPM001585A
- Serial Number SPM001588A
- Serial Number SPM001589A
- Serial Number SPM001611A
- Serial Number SPM001619A
Distribution
Distribution scope not specified by the agency.
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