TriClip Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Transcatheter Tricuspid Valve Repair · First cleared Aug 2025

Total Reports

1,204

Reports (30d)

57

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Single Leaflet Device Attachment During Procedure

limited, registry, incident, rates, based

110

reports

2

Literature Batch: Tricuspid Repair Outcomes

18

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Active safety signals

Increasing trendcriticalDisproportionate reportinghigh

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.