Jenavalve Technology Inc.: Aortic Valve, Prosthesis, Percutaneously Delivered
- Recalling firm
- Jenavalve Technology Inc.
- Product
- JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
- Reason
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d24120e5-14d1-4a01-9f7c-f45fe4a4b8e1