Medtronic recalls CareLink SmartSync Device Manager (24970A) due to software overestimating device longevity, potentially leading to premature replacement. All units with serial numbers are affected.
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).
Medtronic is recalling its CareLink SmartSync Device Manager (24970A) because its software may overestimate how long the device will last, which could cause it to be replaced too early. This affects patients with cardiac implants who use the device to check their device health.
The software overestimates the device's remaining lifespan by about 6 months before it should be replaced. This could lead to the device being replaced earlier than necessary, but it does not cause immediate harm or injury.
Patients with cardiac implants who use the CareLink SmartSync Device Manager (24970A) are affected. Those who have the device and its serial number are most at risk.
Check if your CareLink SmartSync Device Manager (24970A) has a serial number. The product is used to check cardiac implantable electronic devices (CIEDs).
Identify the serial number on your CareLink SmartSync Device Manager (24970A) to confirm it is affected.
No, the recall does not cause immediate harm or injury. The software overestimates device lifespan, which may lead to premature replacement but not an immediate risk.
The software may show the device will last longer than it actually will, potentially causing it to be replaced earlier than necessary.
Check your device's serial number to confirm it is affected. The recall does not require immediate action beyond identifying the device.
We’ve drafted a message you can send Medtr: CRHF to request your refund or repair — edit it as you like.
Subject: Recall Z-1522-2021 — Medtr: CRHF Medtr: CRHF Hello, I own a Medtr: CRHF that is covered by recall Z-1522-2021 from Medtr: CRHF. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
