Accessories Bubble Sensor 3/8“ x 3/32“Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04033817902447), received between May 7, 2024 and May 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Readings” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 16, 2025Failure to Auto Stop; Failure to Auto Stop

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR ALARMED AND STOPPED THE PUMP, CORRECTLY. HOWEVER, THE SECOND TIME IT ALARMED, A FEW MINUTES AFTER THE PREVIOUS ALARM, IT SOUNDED BUT DID NOT STOP THE PUMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036143 ↗
• MalfunctionFeb 18, 2025Low Readings; Low Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393398 ↗
• MalfunctionSep 10, 2024Break; Low Readings; Break; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE DURING PROCEDURE. 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 20178094 ↗
• MalfunctionMay 7, 2024Under-Sensing; Low Readings; Under-Sensing; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, THE 3/8 ARTERIAL BUBBLE SENSOR WAS NOT TRIGGERING ALARM WHEN TESTED (AIR IN TUBE) DURING IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257756 ↗

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