Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Manufacturing error that may have resulted in a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.
Affected Products
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Quantity: 3 units
Why Was This Recalled?
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report