Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PRIMO MRI VR 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
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Quantity: 46 units
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