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Trilogy Delivery Catheter recallZ-0135-2027 · Jenavalve Technology Inc. · initiated Jul 31, 2026

Open, Classified All recalls posted in October 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Jenavalve Technology Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 Delivery Catheters. If you prefer to return the products yourself, please contact us at 866-588-8287 and we will provide you with an RGA number prior to you shipping them to: JenaValve Technology Inc., 4 Cromwell, Irvine, California 92618, USA; Attn: Quality Department; Reference: FA26001 4. Please complete and sign the Business reply form (BRF) of this letter and email it to [email protected] or give it to your JenaValve field representative. 5. Upon receipt of the completed BRF and returned product, JenaValve will provide replacement products. Incomplete BRFs cannot be processed. 6. If any of the subject Trilogy Delivery Catheters have been transferred to another facility, identify the receiving facility on the Business Reply Form, contact [email protected], and provide a copy of this letter to the relevant personnel.

Recall details

Recall number
Z-0135-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Jul 31, 2026
Posted by the FDA
Oct 9, 2026
Recalling firm
Jenavalve Technology Inc.
Quantity
108 units
Product code
NPT
FDA submissions
P250024
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.

Product description

JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M

Code information (models, lots, serial numbers)

GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 99697).

Sources and updates

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