CareLink SmartSync limited the window to abort a high voltage therapy

Plain-English summary

The Medtronic CareLink SmartSync Device Manager, model number 24967A, is being recalled across its software components, including the Cobalt Crome application (software model D00U005) and the Claria Amplia Compia application. The action covers 22,091 devices in total.

According to the manufacturer, in prior SmartSync application versions the Abort button stopped the test that was selected. During an induction test there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States. The software is used by healthcare facilities rather than sold to consumers.

Facilities should identify affected installations using the software model numbers and GTINs in the recall notice and follow the instructions issued by Medtronic.

The recalled product

Product

Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod

Manufacturer

Medtronic, Inc.

Category

Medical Device — Cardiac device programmer

Hazard

• abort-window
• high-voltage-therapy
• induction-test
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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