Trilogy Delivery CatheterRecalls & reported problems across all models

We found 3 models of Trilogy Delivery Catheter by Jenavalve Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 7, 2026 and Aug 7, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Trilogy Delivery Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 31, 2026Open, Classified

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

   Z-0136-2027 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jul 31, 2026Open, Classified

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

   Z-0135-2027 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jul 31, 2026Open, Classified

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

   Z-0134-2027 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Trilogy Delivery Catheter problems

Trilogy Delivery Catheter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Trilogy Delivery Catheter TRILOGY-DC-L

  Aortic Valve, Prosthesis, Percutaneously Delivered
  1 recall1 report
• Trilogy Delivery Catheter TRILOGY-DC-S

  Aortic Valve, Prosthesis, Percutaneously Delivered
  1 recall0 reports
• Trilogy Delivery Catheter TRILOGY-DC-M

  Aortic Valve, Prosthesis, Percutaneously Delivered
  1 recall0 reports

Recent Trilogy Delivery Catheter adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Human-Device Interface Problem

  It was reported that during a transcatheter aortic valve (THV) procedure, a 27mm Trilogy Heart Valve was successfully deployed. Following deployment, the physician encountered difficulty withdrawing the delivery catheter into the sheath during delivery system removal. Deformation at the sheath tip was observed after retrieval.  This resulted in injury to the femoral artery, and vascular surgery was performed to repair femoral artery. The delivery catheter is not available for return.A full device history record review of the system was conducted, and all system components met acceptance criteria. Instructions for use indicate on 7.5.3 step include the following: "CAUTION Do not retract the Delivery Catheter if resistance is encountered at the introducer Sheath tip ad this can damage the Sleeve and/or introducer Sheath and lead to vascular damage during the system withdrawal. Instead, reposition the introducer Sheath to ensure proper alignment with the Sleeve under fluoroscopy and slowly retract the Sleeve into the Introducer Sheath"

  Patient problems: Perforation of Vessels

  MAUDE report 50184032 ↗