Official recall record

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1.

US FDA — Medical Devices · 2025-06-17 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-06-17
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00763000002039
Brand on record: Medtronic, Inc.

What the authority reported

A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
2025-06-17 · US FDA — Medical Devices
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo
2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr

Other recalls from this brand

2026-03-11 · US FDA — Medical Devices
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment o
2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:
2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1.

All 6 official recall notices naming Medtronic, Inc. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.