Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to The device may contain a manufacturing defect of...
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 HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Quantity: 2 units
Why Was This Recalled?
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
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