Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COBALT DR MRI SureScan Recalled by Medtronic Inc. Due to Potential for manufacturing defect. Weld crack led to...
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. directly.
Affected Products
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Quantity: 9
Why Was This Recalled?
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc.
Medtronic Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report