Recall Z-1449-2020— Medtronic CoreValve LLC
Class II · Ongoing
Class II FDA medical device recall by Medtronic CoreValve LLC, initiated 2020-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.. 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..
- Recalling firm
- Medtronic CoreValve LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-01-14
- Firm location
- Santa Ana, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.