ClaripulseClaripulse™
Get Early Access
Back to Structural Heart

MitraClip Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Transcatheter Mitral Valve Repair (TEER) · First cleared Jul 2014 · 17 device variants grouped

Total Reports

18,209

Reports (30d)

249

Active Signals

15

Open Recalls

3

Monthly Report Volume
No timeline data available.
Event Type Breakdown
No event type data available.

Detection

Active safety signals

Increasing trendcriticalDisproportionate reportinghighVolume spikehighIncreasing trendcriticalDisproportionate reportinghighDisproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Sep 8, 2022 · Open, Classified

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

Class II

Sep 8, 2022 · Open, Classified

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

Class II

Sep 8, 2022 · Open, Classified

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

Keep exploring

Related devices in Structural

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Edwards Lifesciences LLC · 13,485 reports

→

Evolut FX

MEDTRONIC, INC. · 12,636 reports

→

Evolut PRO

MEDTRONIC, INC. · 7,566 reports

→

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC

Edwards Lifesciences LLC · 6,121 reports

→

CoreValve Evolut

MEDTRONIC, INC. · 4,371 reports

→

WATCHMAN

BOSTON SCIENTIFIC CORPORATION · 3,826 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 15 active signals detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→
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.