FDA-Device2020-03-18Class II
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Medtronic CoreValve LLC
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.
Sold states
US Nationwide distribution in the states of Ohio and Kansas.
Affected count
6
Manufactured in
1851 E Deere Ave, Santa Ana, CA, United States
Products
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2020Don't want to check this manually?
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