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Recall Observatory FDA recall evidence

Device product

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

Z-1449-2020

January 14, 2020

Class II

Product summary

Firm
Medtronic CoreValve LLC
Event
Event 84837
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-1449-2020

Official wording

Reason: 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.

Code information: GTIN: 00643169707535

Distribution pattern: US Nationwide distribution in the states of Ohio and Kansas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.