Medtronic CoreValve LLC recalls Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit
Recalled Product
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Hazard / Issue
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.
Issued by
FDA
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