Medtronic recalls CareLink SmartSync Device Manager for potential longevity estimation errors in early device life when unipolar pacing vectors are programmed. No other features affected.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
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📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic CareLink SmartSync Device Manager Recall: Longevity Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62849-medtronic-carelink-smartsync-device-manager-recall-longevity-error-risk. Based on FDA recall #Z-1528-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2021%22&limit=1).
The FDA announced on April 6, 2021, that Medtronic Inc. is recalling CareLink SmartSync Device Managers due to a longevity estimation error in the early years of device life. The recall affects 16,311 units distributed worldwide.
How to tell if you have it
Brand: CareLink
Product: CareLink SmartSync Device Manager
Model Number: 24970A
Quantity: 16,311 units
The hazard
According to the FDA, a longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has had 29 other recalls on record since December 19, 2017. Recent similar recalls include Medtronic ICDs with glassed feedthrough risk of reduced energy output during high voltage therapy (May 10, 2023), Crome Implantable Defibrillators: Reduced Shock Energy During High-Voltage Therapy (June 22, 2022), and Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots (April 20, 2022). Other recent recalls of similar products include Philips Telemetry Monitor 5500 1.4 GHz Recall: Risk of Device Reset Causing Connection Failure (June 5, 2026), Philips IntelliVue MX40: Patient Monitor May Not Alarm - Recall (October 31, 2025), and Philips Cardiac Workstation 7000: Inaccurate Heart Rate Data Risk (July 1, 2026).
How to tell if you have this one
Check if your device has the model number 24970A for CareLink SmartSync Device Manager. The product is used for treating arrhythmias related to bradycardia or heart failure.
Brand
Medtr: CareLink
Category
Medical device
FDA recall event · 4 products
All 4 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 distribution.
Recall number
Product, codes & lots
Quantity
Z-1525-2021
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.; all codes
575815 units
Z-1526-2021
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.; all codes
333408 units
Z-1527-2021
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore; all codes
37690 units
Z-1528-2021
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A; all codes
16,311 units
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify if unipolar pacing vectors are programmed in the right atrial or ventricular leads.
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-1528-2021 (April 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1528-2021 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.