TruaceTracing the truth around AIWednesday, August 26, 2026
TRV-2026-0046Retracted — remains on the recordOfficial statistics

Triclip delivery system (tcds): FDA death report involving AI

The FDA received a death report involving Triclip delivery system (tcds), made by Abbott medical. The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…

Health · P Space — documented harm · certified 2026-07-12 · v2 · article view · machine-readable

This record was retracted on 2026-07-13Model backfill: source did not support a publishable AI-impact claim. It remains permanently retrievable here, as does every prior version below.
Current reading — problem

An FDA adverse-event report linked Triclip delivery system (tcds) to an AI-related death; the report requires investigation and does not by itself establish causality.

What this doesn’t fix

FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.

Evidence

Cite this record

Truvace Impact Record TRV-2026-0046, v2: “Triclip delivery system (tcds): FDA death report involving AI.” Truvace, 2026-07-13. /record/TRV-2026-0046 (accessed at citation time). sha256 6bb0c8ae18e10de3

Calibration history

Every change to this record since certification, in the open.

  1. Retractedv26bb0c8ae18e1

    Model backfill: source did not support a publishable AI-impact claim

  2. Certifiedv13305d13a10d7

    Certified into the record

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