Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1480-2022.
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1480-2022.
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-1480-2022.
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). The notice was published on November 5, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 3 units are potentially affected.