MANTA Adverse Events: FDA MAUDE Data

ESSENTIAL MEDICAL, INC. · Vascular Hemostasis/Closure Device · First cleared Jun 2024

Total Reports

1,009

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Single-center comparative study of MANTA and ProGlide vascular closure devices in percutaneous endovascular aneurysm repair.

Oosterveld RJ, et al. · 2025

Ipsilateral Safety Wire as Bailout for MANTA Failure in Patients Undergoing Transcatheter Aortic Valve Replacement.

Imran H, et al. · 2025

Deep-Sea Biomimetic Manta Ray Robots: A Comprehensive Review Based on Operational Depth Spectrum, Structures, Energy Optimization, and Control Systems.

Ye L, et al. · 2026

Utilizing deep belief network optimized by balanced Manta ray foraging optimization algorithm for estimating the shear Wall's shear strength.

Liu F, et al. · 2025

Unravelling the genetic architecture of cardiovascular disease through structural variant detection with whole-genome sequencing.

Colombage DNP, et al. · 2026

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.