Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error
Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where a software error could lead to delayed replacement of cardiac devices, but no injuries or illnesses have been reported.
Plain-English summary
Medtronic Inc. is recalling 16,311 CareLink SmartSync Device Manager units (model 24970A) distributed worldwide. These devices are used by healthcare professionals to interrogate cardiac implantable electronic devices (CIEDs).
The recall is due to a software issue that can cause the device to overestimate the displayed longevity of the implanted devices. This error may occur during an approximate six-month window before the implanted device triggers its Recommended Replacement Time (RRT).
Healthcare providers using these devices should contact Medtronic for further instructions on how to address the software issue.
The recalled product
- Product
- CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
- Affected units
- 16,311
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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