Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall JenaValve Trilogy Delivery Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall JenaValve Trilogy Delivery Cathetersee related information
Date Initiated by FirmJuly 31, 2026
Date PostedOctober 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0135-2027
Recall Event ID 99697
PMA NumberP250024 
Product Classification Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
ProductJenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Code Information GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001
FEI Number 3012148004
Recalling Firm/
Manufacturer		 Jenavalve Technology Inc.
4 Cromwell
Irvine CA 92618-1816
For Additional Information ContactJohn Kilcoyne
+1-949-767-2110 Ext. 1030
Manufacturer Reason
for Recall		Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 customersupport.us@jenavalve.com 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 customersupport.us@jenavalve.com, and provide a copy of this letter to the relevant personnel.
Quantity in Commerce108 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NPT
-
-