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Medtronic CoreValve Recalls
2 recalls on record · March 18, 2020 to March 18, 2020 · Medical Devices
March 18, 2020Medical DevicesFDA
Medtronic CoreValve LLC recalls Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardi
Hazard: 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.
March 18, 2020Medical DevicesFDA
Medtronic CoreValve LLC recalls Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid val
Hazard: 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.