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Medtronic CoreValve LLC recalls Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardi
Recalled March 18, 2020 · FDA recall Z-1450-2020 · Medtronic CoreValve
Hazard
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. · FDA Class II
Units
6
Sold at
US Nationwide distribution in the states of Ohio and Kansas.
Description
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.
Product
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Manufacturer(s)
Medtronic CoreValve LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →