CareLink SmartSync Device Manager recall: Software Issue
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Why was CareLink SmartSync Device Manager recalled?
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 16,311 devices
- Distribution
- Worldwide
- Recall date
- May 12, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)