+ HEALTH Aims Intramuscular fat (IMF) is increasingly recognized as a marker of ectopic adiposity and adverse cardiome…+ HEALTH Periapical lesions are challenging to detect on intraoral radiographs because of anatomical superimposition a…± HEALTH Ultrasound imaging is an indispensable diagnostic tool, yet its profound reliance on operator expertise inher…+ HEALTH Objectives We adapted the individualized polysocial risk score (iPsRS), a machine learning model originally d…± HEALTH Melioidosis is a life-threatening infectious disease caused by Burkholderia pseudomallei ( Bp ). Rapid diagno…+ HEALTH Classification is a core machine learning task, and ensemble voting methods are widely used to improve predic…+ CLIMATE Microplastic (MP) pollution poses escalating environmental risks, demanding efficient and reproducible tools…± HEALTH Medicinal chemistry sits at the center of modern drug discovery, yet translating molecular designs into appro…
TruaceTracing the truth around AIThursday, August 27, 2026
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TRV-2026-0038Retracted — remains on the recordOfficial statistics

Mitraclip® system clip delivery system: FDA death report involving AI

The FDA received a death report involving Mitraclip® system clip delivery system, 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-e…

Health · P Space — documented harm · certified 2026-07-12 · v3 · article view · machine-readable

This record was retracted on 2026-07-13 — Model backfill: source did not support a publishable AI-impact claim.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 Mitraclip® system clip delivery system 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-2026-0038, v3: “Mitraclip® system clip delivery system: FDA death report involving AI.” Truvace, 2026-07-13. /record/TRV-2026-0038 (accessed at citation time). sha256 07fd157b3942a4e6…

Calibration history

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

  1. Retractedv307fd157b3942…

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

  2. Revisedv2896d13e72c21…

    Reading revised

  3. Certifiedv1729af51855ec…

    Certified into the record

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