The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0136-2027·Announced 2026-10-21

JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

Jenavalve Technology Inc. is recalling 143 JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a defect that may result in the inability to deploy a heart valve device. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Jenavalve Technology Inc. is recalling 143 units of the JenaValve Trilogy Delivery Catheter, Size 27MM (REF: TRILOGY-DC-L). The recall was initiated because the delivery catheter may have sleeve liner separation, which can result in difficulty or inability to deploy the heart valve device.

The affected products were distributed nationwide in the United States, specifically in Arizona, California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, and Washington. The products were also distributed in Germany, Denmark, Great Britain, and Italy. Specific lot numbers are listed in the agency's recall record.

Healthcare providers and consumers should stop using the affected catheters and contact Jenavalve Technology Inc. for further instructions or a replacement.

The recalled product

Product
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Manufacturer
Jenavalve Technology Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
143

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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