FDA-Device2026-10-27Class IIPROCESSING DEFECT
Medtronic CareLink SmartSync app recalled for longevity estimate error
What this means
Medtronic is recalling the CareLink SmartSync Device Manager App (Model M01A02), which is used with permanent implantable pulse generators. A software problem may cause the device's displayed longevity estimate to be inaccurate. About 38,115 units are affected, and no injuries have been reported.
- Talk to your cardiologist or device clinic about the longevity estimate shown for your implanted device.
- Do not change or stop your device or follow-up care without first talking to your doctor.
The agency's original wording
Hazard
Software problem has the potential for an inaccurate displayed longevity estimate.
Intended for
Adults (under 0 months)
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
38115 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Products
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Products in this recall · 3
The agency lists each product in this recall separately. Check every one you might have.
- CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantableZ-0302-2027 · 11238 units
- CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantableZ-0303-2027 · 11741 units
- CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable (this page)Z-0304-2027 · 38115 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0304-2027More Medtronic recalls
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