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Z-0136-2027Class II

Jenavalve Technology Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Jenavalve Technology Inc.
Product type
Device
Status
Ongoing
Report date
2026-10-21
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.
Firm state
CA
Product quantity
143 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

Code / lot 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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →