Santa Ana, CA, United States
Medtronic CoreValve LLC recalls
1 recall recorded since 2018, most recently on 14 January 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 January 2020
- 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.
- Distribution
- US Nationwide distribution in the states of Ohio and Kansas.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1450-2020, Z-1449-2020
- Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.