Medtronic recalls Cobalt XT VR, VR, DR, HF and HF Quad models with CareLink SmartSync Device Manager software D00U005 due to potential telemetry errors that could affect implantable cardioverter defibrillators.
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Medtronic is recalling specific Cobalt models with CareLink SmartSync Device Manager software D00U005 because of a telemetry error that may cause issues with their implantable cardioverter defibrillators. This could lead to improper device communication with the patient's heart. Affected models include Cobalt XT VR, VR, DR, HF and HF Quad series.
The telemetry error may cause the device to communicate incorrectly with the patient's heart, potentially leading to improper treatment or failure to detect heart issues. This could result in the device not functioning as intended, which might cause health risks for patients with heart conditions.
Patients with Medtronic Cobalt implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the specific models and software versions listed in the recall. Most at risk are those who have the affected models and are currently using the CareLink SmartSync Device Manager application software.
Check if your device model matches the Cobalt XT VR (DVPA2D1, DVPA2D4), Cobalt VR (DVPB3D1, DVPB3D4), Cobalt XT DR (DDPA2D1, DDPA2D4), Cobalt DR (DDPB3D1, DDPB3D4), Cobalt XT HF (DTPA2D4, DTPA2D1), Cobalt HF (DTPB2D4, DTPB2D1), Cobalt XT HF Quad (DTPA2QQ, DTPA2Q1), or Cobalt HF Quad (DTPB2QQ, DTPB2Q1) models. Also check for the CareLink SmartSync Device Manager software version D00U005.
Identify your device model by checking the label on the device or the software settings. Compare it to the list of affected models provided in the recall.
Check if your device has the CareLink SmartSync Device Manager software version D00U005 by looking at the software settings or contacting your healthcare provider.
If you have an affected device, contact your healthcare provider for guidance on next steps and potential device checks or replacements.
No, you do not need to stop using your device immediately. However, you should check if your device is affected and contact your healthcare provider for guidance.
If your device is affected, contact your healthcare provider for instructions on how to proceed. They may recommend a device check or replacement.
Check your device model against the list of affected models in the recall and verify if your device has the CareLink SmartSync Device Manager software version D00U005.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1267-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1267-2022 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.
