Trilogy Delivery Catheter TRILOGY-DC-LRecalls & reported problems

Jenavalve Technology, Inc. · Transfemoral Delivery Catheter, Size 27MM · Class 3

All models of Trilogy Delivery Catheter (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850000898158), 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).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

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 ↗

Most reported problems

Device problems

Human-Device Interface Problem1

Patient problems

Perforation of Vessels1

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗

Device details

UDI-DI	`00850000898158`
Brand	Trilogy Delivery Catheter
Model	TRILOGY-DC-L
Company	Jenavalve Technology, Inc.
Product code	NPT · Aortic Valve, Prosthesis, Percutaneously Delivered
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 19, 2026

Device type (GMDN): Vascular guide-catheter, single-use

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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