Z-1449-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- January 14, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
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.
Distribution Pattern
US Nationwide distribution in the states of Ohio and Kansas.
Code Information
GTIN: 00643169707535