Recall Z-0304-2027— Medtronic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic, Inc., initiated 2026-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable. Reason: Software problem has the potential for an inaccurate displayed longevity estimate..
- Recalling firm
- Medtronic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-24
- Firm location
- Mounds View, MN, United States
Product description
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Reason for recall
Software problem has the potential for an inaccurate displayed longevity estimate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.