FDA-Device2026-10-27Class IIPROCESSING DEFECT
Medtronic CareLink SmartSync programmer recalled over battery longevity display
What this means
Medtronic is recalling about 11,238 CareLink SmartSync Programmers (Model 24970A), which are used with implanted pulse generators. A software problem may cause the programmer to show an inaccurate estimate of how long an implanted device's battery will last. No injuries have been reported.
- Clinics and providers using this programmer should check whether their unit's serial number is listed in the recall notice.
- Patients with an implanted device should ask their device clinic or cardiologist whether this programmer was used for their battery check.
- Contact Medtronic for instructions on the correction for affected programmers.
The agency's original wording
Hazard
Software problem has the potential for an inaccurate displayed longevity estimate.
Intended for
Adults (18 years to 100 years)
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
11238 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Products
CareLink SmartSync Programmer, Model 24970A, 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, implantable (this page)Z-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, implantableZ-0304-2027 · 38115 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0302-2027More Medtronic recalls
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