Medtronic Crome models loaded with CareLink SmartSync Device Manager software D00U005 have a telemetry error that may cause issues with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Medtronic has recalled specific Crome models loaded with CareLink SmartSync Device Manager software version D00U005 due to a potential telemetry error that could affect implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This recall is for devices that may not function properly and could lead to health risks.
The recall addresses a telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This error could potentially cause the device to malfunction, leading to improper monitoring or treatment of heart conditions.
Patients with Medtronic Crome models (VR, DR, HF, or HF Quad) that have the CareLink SmartSync Device Manager software version D00U005 are affected. Those with the specific model numbers and serial numbers listed in the recall are most at risk.
Check if your Medtronic Crome device has the CareLink SmartSync Device Manager software version D00U005. The affected models include VR (DVPC3D1, DVPC3D4), DR (DDPC3D1, DDPC3D4), HF (DTPC2D4, DTPC2D1), and HF Quad (DTPC2QQ, DTPC2Q1) with specific serial numbers and GTINs listed in the recall.
Verify if your device has the CareLink SmartSync Device Manager software version D00U005 by checking the device settings or manual.
Reach out to Medtronic directly to confirm if your device is affected and to get instructions on next steps.
The affected models are Crome VR (DVPC3D1, DVPC3D4), Crome DR (DDPC3D1, DDPC3D4), Crome HF (DTPC2D4, DTPC2D1), and Crome HF Quad (DTPC2QQ, DTPC2Q1) with CareLink SmartSync Device Manager software version D00U005.
Check your device's software version by looking at the settings or manual. If it has CareLink SmartSync Device Manager software version D00U005, it is affected.
Contact Medtronic directly to confirm if your device is affected and to get instructions on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1268-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1268-2022 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.
