Medtronic CareLink SmartSync Software Recall: Data Processing Failure Risk
Medtronic recalls CareLink SmartSync Device Manager software (D00U005) for Cobalt and Crome ICDs/CRT-Ds due to potential data processing failures. Affected units may not correctly track heart health episodes.
Lower-risk recall
The processing of collected episode data may fail due to a software error.
Contact the company
What happened, in plain English
Medtronic is recalling CareLink SmartSync software version D00U005 for specific heart devices. This software may fail to process heart health data correctly, potentially leading to inaccurate episode tracking. Read more at govinfonow.com/recall/61696-medtronic-carelink-smartsync-software-recall-data-processing-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61696-medtronic-carelink-smartsync-software-recall-data-processing-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0282-2022
Cite this page
“Medtronic CareLink SmartSync Software Recall: Data Processing Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61696-medtronic-carelink-smartsync-software-recall-data-processing-failure-risk. Based on FDA recall #Z-0282-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0282-2022%22&limit=1).
Why it’s dangerous
The software may fail to properly process heart health data collected by the device. This could result in inaccurate tracking of episodes that require medical attention. However, the recall does not indicate immediate safety risks to patients.
Who’s affected
Patients with Medtronic Cobalt or Crome implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the affected software version. Those with the specific device model numbers listed in the recall are most at risk.
How to tell if you have this one
Check if your device model matches the listed Cobalt or Crome models (e.g., Cobalt XT VR: DVPA2D1, DVPA2D4) and if you're using software version below v5.0.0.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Software Version
Verify your CareLink SmartSync software version is at least v5.0.0 by checking your device settings.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide. There was military/government distribution. The countries of Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if my software is older than v5.0.0?
Update to software version v5.0.0 or higher as the recall specifies this version is affected.
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Where this comes from
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-0282-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0282-2022 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.