Medtronic CareLink SmartSync Device Manager App Software Recall
Medtronic is recalling the CareLink SmartSync Device Manager App due to a software problem that may cause inaccurate displayed longevity estimates for implantable 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 FDA Class II, and the source identifies a software problem that may result in an inaccurate displayed longevity estimate. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic, Inc. is recalling the CareLink SmartSync Device Manager App, Model M01A02, which is used with permanent implantable pulse generators. The recall involves 38,115 units that were distributed worldwide.
The recall is being issued because a software problem has the potential for an inaccurate displayed longevity estimate. This issue affects the information displayed to users regarding the remaining life of the device.
The source text does not provide specific instructions for consumers or patients on how to proceed, nor does it report any illnesses, injuries, or deaths associated with this software issue.
The recalled product
- Product
- CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
- Manufacturer
- Medtronic, Inc.
- Category
- Medical Device — Software
- Affected units
- 38,115
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 none
- Serial Numbers: C2TM4QV0XC
- DL269KH953
- DVP79R6KV6
- FDG69FQX19
- FHHG9CHX3H
- FVFVMVPK7N
- FVQYCR34T1
- FYJPFH6099
- G19LC9X7J7
- G2VQP97D2J
- GR4R69G4VN
- GW7TFH7HQ0
- GX44D2GDP4
- H3G0Q6W9T7
- H3QGWTYW42
- H9GX6NHL45
- HD2104VHK2
- HD972G7JFV
- HK212M19PD
Distribution
Distribution scope not specified by the agency.
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