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ARROW IABP Adverse Events: FDA MAUDE Data

TELEFLEX INCORPORATED · Intra-Aortic Balloon Pump System (IABP) · First cleared Oct 1998 · 242 device variants grouped

Total Reports

5,444

Reports (30d)

195

Active Signals

14

Open Recalls

34

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Helium Leak with Alarm Activation

intra, intra aortic, harm, aortic, aortic balloon

172

reports

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

Detection

Active safety signals

ChangepointhighNew problem typehighVolume spikehighIncreasing trendmediumChangepointhighDisproportionate reportingmedium

Regulatory

FDA recalls for this device

Class I

Apr 29, 2024 · Open, Classified

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Class I

Apr 29, 2024 · Open, Classified

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Class I

Apr 29, 2024 · Open, Classified

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Class I

Oct 17, 2022 · Open, Classified

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Class I

Oct 17, 2022 · Open, Classified

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Class I

Oct 17, 2022 · Open, Classified

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

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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.