Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to Recalled by Medtronic CoreValve LLC Due to Demonstration Simulus Reusable Sizer Accessory Kits were being...
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 CoreValve LLC directly.
Affected Products
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Quantity: 6
Why Was This Recalled?
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic CoreValve LLC
Medtronic CoreValve LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report