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).
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Contact the company
📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic CareLink SmartSync Device Manager: Overestimates Device Lifespan.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62846-medtronic-carelink-smartsync-device-manager-overestimates-device-lifespan. Based on FDA recall #Z-1522-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1522-2021%22&limit=1).
The FDA announced on April 6, 2021, that Medtronic Inc. is recalling CareLink SmartSync Device Manager (24970A) units due to a software issue that overestimates device longevity. This affects approximately 16,311 devices distributed worldwide.
How to tell if you have it
CareLink SmartSync Device Manager (24970A)
All serial numbers
The hazard
According to the FDA, a SmartSync software issue results in an overestimation of displayed longevity for cardiac implantable electronic devices during an approximate six-month window before the device triggers its Recommended Replacement Time.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since December 19, 2017. Other recent recalls of similar products include Philips Cardiac Workstation 7000: Inaccurate Heart Rate Data Risk (July 1, 2026), COAPTIUM CONNECT Medical Device Shelf Life Recall: Risk of Unusable Device After 26 Months (June 15, 2026), and Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety (March 19, 2026).
How to tell if you have this one
Check if your CareLink SmartSync Device Manager (24970A) has a serial number. The product is used to check cardiac implantable electronic devices (CIEDs).
Brand
Medtr: CRHF
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide
Recall number
Product, codes & lots
Quantity
Z-1522-2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).; All serial numbers
16,311 devices
Z-1523-2021
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT); all serial numbers
45,411 devices
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Identify the serial number on your CareLink SmartSync Device Manager (24970A) to confirm it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1522-2021 (April 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1522-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.