Irvine, CA, United States
Jenavalve Technology Inc. recalls
1 recall recorded since 2018, most recently on 31 July 2026. 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
- 31 July 2026
- Reason
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0136-2027, Z-0135-2027, Z-0134-2027
- JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
- JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
- JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
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.