medical MODERATE Updated 2026-10-21

Jenavalve Technology Inc. recalls JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for JenaValve Trilogy Delivery Catheter, →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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