Is Jenavalve Technology Inc. recalled?

Yes — a recall has been published. Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S

Check the device or its packaging for

GTIN - 00850000898134/ Lot: DS-040826-003 DS-042326-003, DS-042726-006, DS-042826-005, DS-050426-007, DS-050626-002, DS-050626-006, DS-050626-009, DS-050726-005

Why: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
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.
Company: Jenavalve Technology Inc.
Announced: 21 October 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 31 July 2026

Source: FDA record Z-0134-2027 · retrieved 9 October 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.