Accessories Bubble Sensor 3/16“ x 1/16”Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04033817902423), received between Aug 21, 2024 and Sep 3, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Low Readings” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K232291); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CARDIOPLEGIA BUBBLE SENSOR ALARMED FIVE (5) DIFFERENT TIMES DURING THE INITIAL DOSE OF CARDIOPLEGIA. NO AIR WAS OBSERVED IN ALL INSTANCES AND THE ALARM WAS CLEARED. THE PATIENT WAS PLACED ON A RVAD DEVICE POST CARDIOPULMONARY BYPASS, PURPORTEDLY DUE TO MYOCARDIAL PROTECTION.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20125726 ↗
• InjurySep 3, 2024Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CARDIOPLEGIA BUBBLE SENSOR ALARMED FIVE (5) DIFFERENT TIMES DURING THE INITIAL DOSE OF CARDIOPLEGIA. NO AIR WAS OBSERVED IN ALL INSTANCES AND THE ALARM WAS CLEARED. THE PATIENT WAS PLACED ON A RVAD DEVICE POST CARDIOPULMONARY BYPASS, PURPORTEDLY DUE TO MYOCARDIAL PROTECTION.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20125721 ↗
• MalfunctionAug 21, 2024Defective Alarm; Defective Alarm

  LIVANOVA RECEIVED A REPORT ABOUT BUBBLE SENSOR ALARM NOT TRIGGERED. AT THE REMOVAL OF CROSS CLAMP AND DECANNULATING OF THE AORTIC ROOT VENT, THE CARDIOPLEGIA LINE WAS DRAINED BACK OF BLOOD VIA GRAVITY. WHEN THE AIR/BLOOD INTERFACE PASSED THROUGH THE CARDIOPLEGIA BUBBLE SENSOR, THE ALARM DID NOT ACTIVATE. THE SENSOR WAS INSPECTED, WITH THE LATCH OF THE SENSOR THEN OPENED, BUT STILL, THE ALARM DID NOT GO OFF. IT WAS NOT UNTIL THE BUBBLE SENSOR WAS TURNED OFF AND BACK ON, THAT THE ALARM ACTIVATED AND THE ORANGE AUDIBLE AND VISUAL ALARM WAS OCCURRED. THE PRE-BYPASS CHECKS OF ALL SENSORS WAS COMPLETED, AND THE ALARM PERFORMED AS IT SHOULD. THERE WAS NOT PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019977 ↗
• MalfunctionAug 21, 2024Defective Device; Defective Device

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018793 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232291. One submission often covers many models, so check the product and lot details in each record.

• Z-0571-2025 · Oct 18, 2024 · Open, Classified
  Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software