Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Cobalt DR MRI SureScan DDPB3D1 Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Under rare circumstances, the component may be susceptible...
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
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Quantity: 2 units
Why Was This Recalled?
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Where Was This Sold?
This product was distributed to 3 states: GA, NJ, PA
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