CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

JenaValve Trilogy Delivery Catheter, Size recalled

Jenavalve Technology is recalling JenaValve Trilogy Delivery Catheter, Size, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001

Quantity recalled108 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0135-2027
FDA event ID: 99697
Recalling firm: Jenavalve Technology, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2026
FDA classified: 9 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

31 Jul 2026	Recall initiated by company
9 Oct 2026	Classified by FDA	+70 days
21 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Florida Georgia Illinois Massachusetts Maryland Michigan Minnesota Missouri New York Ohio Pennsylvania South Carolina Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99697

This product is part of a recall event; the main page for the event is JenaValve Trilogy Delivery Catheter, Size recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide

More recalls from Jenavalve Technology

All 3

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide

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21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
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