Medtronic CoreValve LLC recalls Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac…

Recall date

January 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1450-2020

FDA classification

Class II

Brand / firm

Medtronic CoreValve LLC

Sold / distributed

US Nationwide distribution in the states of Ohio and Kansas.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.