Bubble DetectorRecalls & reported problems across all models

We found 4 models of Bubble Detector by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and Sep 23, 2026 — classified as 1 death, 36 malfunctions.

The most frequently reported specific device problem is “Low Readings” (24 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bubble Detector problems

Bubble Detector models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bubble Detector Sensor 3/8"

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death26 reports
• Bubble Detector Sensor 1/4"

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• Bubble Detector Sensor 3/16"

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• Bubble Detector Sensor Module

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports

Recent Bubble Detector adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Electrical /Electronic Property Problem

  LivaNova Deutschland received a report of a Bubble Sensor which could not work properly and failed. The event occurred during procedure.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866616 ↗
• MalfunctionSep 21, 2026Low Readings

  LivaNova Deutschland received a report of a Bubble Sensor which could not detect properly bubbles. The event occurred during procedure.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836715 ↗
• MalfunctionSep 21, 2026Low Readings

  LivaNova Deutschland received a report of a Bubble Sensor which could not detect properly bubbles. The event occurred during procedure.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836615 ↗
• MalfunctionJun 24, 2025Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE BUBBLE SENSOR 3/8 NEEDS TO BE REPLACED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318442 ↗
• MalfunctionJun 4, 2025Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE DURING PRIMING. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140837 ↗
• MalfunctionNov 22, 2024Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR IS NOT WORKING DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756849 ↗
• MalfunctionNov 6, 2024False Alarm; Low Readings; False Alarm; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE DETECTOR HAD A POOR REACTION DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620158 ↗
• MalfunctionAug 6, 2024Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS NOT FUNCTIONING DURING PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918296 ↗
• MalfunctionJul 1, 2024False Alarm; Low Readings; False Alarm; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR MALFUNCTIONED DURING MAINTENANCE ACTIVITY. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642195 ↗
• MalfunctionMar 4, 2024Under-Sensing; Under-Sensing

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, A BUBBLE SENSOR DETECTOR WAS ACTIVATED UPON THE DETECTION OF AN AIR BUBBLE, HOWEVER, LATER, IT COULD NOT HAVE DETECTED IT SINCE THE END-USER NOTICED A MASSIVE AIR IN THE CIRCULATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825128 ↗
• MalfunctionDec 29, 2023Low Readings; Deformation Due to Compressive Stress; Low Readings; Deformation Due to Compressive Stress

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T CAUSED A SHORT CIRCUIT, AFTER ITS SWITCHING ON.IN DETAIL, THE BREAKER OF THE SPECIFIC SOCKET WHERE THE 3T SYSTEM WAS PLUGGED IN TRIPPED. THE DEVICE WAS THEN SWITCHED BACK ON AND THE ISSUE HAPPENED AGAIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417463 ↗
• MalfunctionDec 28, 2023Over-Sensing; Low Readings; Over-Sensing; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A BUBBLE SENSOR MALFUNCTION-NOT READING ANYTHING DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407709 ↗
• MalfunctionDec 21, 2023Over-Sensing; Failure to Sense; Over-Sensing; Failure to Sense

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR DID NOT DETECT AIR BUBBLES. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370656 ↗
• MalfunctionOct 11, 2023Over-Sensing; Low Readings; Over-Sensing; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912433 ↗
• DeathOct 4, 2023Low Readings; Low Readings

  SEE INITIAL REPORT.

  Patient problems: Air Embolism

  MAUDE report 17868449 ↗

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