Medtronic CoreValve LLC: Medical Device Recall in 2020 - (Recall #: Z-1450-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 14, 2020

Date Posted: March 18, 2020

Recall Number: Z-1450-2020

Event ID: 84837

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 6

Code Information:

GTIN: 00643169707573

Distribution Pattern:

US Nationwide distribution in the states of Ohio and Kansas.

Voluntary or Mandated:

Voluntary: Firm initiated