Medtronic CoreValve LLC: 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.

Agency Publication Date: February 14, 2020

Affected Products

Product: Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.

GTIN: 00643169707535

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

GTIN: 00643169707573

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84837

Status: Active

Manufacturer: Medtronic CoreValve LLC

Manufactured In: United States

Units Affected: 2 products (6)

Agency Last Updated: March 6, 2020

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Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device