JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Summary
The FDA issued a Class II for JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L by Jenavalve Technology Inc.. Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device..
Details
Source
Device Recall
External ID
Z-0136-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Lot/Code Info: GTIN - 00850000898158/ Lot: DS-040926-004, DS-041026-008, DS-041026-009, DS-042226-006, DS-042226-007, DS-051526-004, DS-051526-006, DS-060226-007, DS-060526-002, DS-060526-003, DS-060526-007
Quantity Affected: 143 units
Reason for Recall
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Jenavalve Technology Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jenavalve Technology Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jenavalve Technology Inc. have FDA actions?
Jenavalve Technology Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0136-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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