Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DT...
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (electrical shock). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1486-2022.
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).
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1486-2022.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1486-2022.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) Recall FAQ
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) is the subject of a medical implants safety report: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DT.... The notice was published on June 22, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 8,429 units are potentially affected.