Recall Z-0136-2027 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
| Date | Oct 9, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| Reason | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| Root cause | Nonconforming Material/Component |
| Action | On the dates of August 1, 4, 6, and 19th, JenaValve Technology Inc. issued a Urgent: Medical Device Recall notification via email. JenaValve asked consignees to take the following actions: 1. Review the information contained in this letter and ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 2. Examine your inventory immediately to determine if you have Trilogy Delivery Catheters from the affected lots and quarantine the subject products. 3. JenaValve field team members will schedule a visit to retrieve the subject Trilogy Deliver |
| Quantity | 143 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.