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ACUITY Steerable Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Mar 2008

Total Reports

230

Reports (30d)

2

Active Signals

0

Open Recalls

4

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Implantable Lead Revision for Infection

infection additional, revision infection, additional adverse, implantable, lead revision

1

reports

2

Lead Revision Due to Infection

explanted right, infection additional, revision infection, additional adverse, lead revision

1

reports

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

Regulatory

FDA recalls for this device

Class I

Jul 24, 2025 · Open, Classified

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Class I

Jul 24, 2025 · Open, Classified

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Class II

Sep 30, 2022 · Open, Classified

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Class II

Sep 30, 2022 · Open, Classified

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

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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.