FDA-Device2026-10-27Class IIPROCESSING DEFECT
Medtronic CareLink SmartSync RF Head recalled for display error
What this means
Medtronic is recalling about 11,741 CareLink SmartSync RF Head patient connectors because a software problem could cause an inaccurate longevity estimate to appear on the display. No injuries have been reported. The FDA has classified this as a Class II recall.
- Check whether your connector's serial number is listed in the FDA notice.
- Talk with your healthcare provider about any longevity estimate you have seen on the display.
- Contact Medtronic for guidance on the software issue and any available remedy.
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
11741 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Products
CareLink SmartSync, RF Head Patient Connector, Model 24967, 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, implantable (this page)Z-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-0303-2027More Medtronic recalls
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