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.
The processing of collected episode data may fail due to a software error.
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.
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.
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.
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.
Verify your CareLink SmartSync software version is at least v5.0.0 by checking your device settings.
No, the recall does not require stopping device use. The issue is with software processing, not device safety.
Update to software version v5.0.0 or higher as the recall specifies this version is affected.
The recall states the software may fail to process data, but does not mention risks of injury or death.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0282-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0282-2022 from Medtronic. 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.
