Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) models DTPC2D4, DTPC2D1, DTPC2QQ, and DTPC2Q1 have a potential for reduced shock energy (~79%) during high-voltage therapy. Affected devices may not deliver full programmed energy, risking inadequate treatment.
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Medtronic's Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) models DTPC2D4, DTPC2D1, DTPC2QQ, and DTPC2Q1 have a potential for reduced shock energy during high-voltage therapy. This could mean the device doesn't deliver full programmed energy, which might lead to inadequate treatment of heart conditions.
The device may deliver only about 79% of the programmed shock energy during high-voltage therapy. This reduction could result in the device not providing sufficient energy to treat heart arrhythmias effectively.
Patients with Crome CRT-D devices listed in the recall are affected. Most at risk are individuals who have these specific models implanted for heart failure or rhythm management.
Check if your device is a Crome CRT-D with model numbers DTPC2D4, DTPC2D1, DTPC2QQ, or DTPC2Q1. Look for the GTIN and serial numbers listed in the recall details.
Identify your device model by checking the model numbers (DTPC2D4, DTPC2D1, DTPC2QQ, DTPC2Q1) and associated GTIN/serial numbers listed in the recall.
If your device is listed in the recall, you should check the model numbers and serial numbers to see if it's affected. The recall does not specify immediate action beyond checking.
The device may deliver only about 79% of the programmed shock energy during high-voltage therapy, which could lead to inadequate treatment of heart conditions.
Check if your device model is DTPC2D4, DTPC2D1, DTPC2QQ, or DTPC2Q1, and verify the GTIN and serial numbers against the list provided in the recall.
We’ve drafted a message you can send Crome to request your refund or repair — edit it as you like.
Subject: Recall Z-1490-2022 — Crome Crome Hello, I own a Crome that is covered by recall Z-1490-2022 from Crome. 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.