Medtronic's Cardiac Rhythm and Heart Failure (CRHF) devices provide advanced cardiac care solutions for patients with heart rhythm disorders and heart failure conditions.
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 CRHF devices are designed to monitor and manage cardiac rhythm and heart failure conditions through advanced technology. These devices help improve patient outcomes by providing precise monitoring and treatment options for various cardiac conditions.
These devices are medical devices that monitor and manage cardiac conditions. They are not inherently dangerous but require proper use and maintenance to ensure patient safety.
Patients with cardiac rhythm disorders and heart failure conditions
Ensure the device is properly calibrated and maintained, follow the manufacturer's instructions for use, and have regular check-ups with healthcare providers.
Check the device's serial number and GTIN to verify it is a genuine Medtronic product.
Ensure the device is properly calibrated and maintained by a certified technician.
Follow the manufacturer's instructions for use and have regular check-ups with healthcare providers.
Medtronic's CRHF devices are designed to monitor and manage cardiac rhythm and heart failure conditions through advanced technology. These devices help improve patient outcomes by providing precise monitoring and treatment options for various cardiac conditions.
It is recommended to have your CRHF device checked by a healthcare provider at least once a year, or as recommended by your doctor based on your specific condition.
If your CRHF device malfunctions, contact your healthcare provider immediately or follow the emergency procedures outlined in the device's user manual.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1486-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1486-2022 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.
