Bubble Detector Sensor 3/8"Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04033817900597), received between Mar 7, 2022 and Sep 23, 2026 — classified as 1 death, 25 malfunctions.

The most frequently reported specific device problem is “Low Readings” (18 reports).

13 other recalls cover devices cleared under the same FDA submission (K071318); 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 25 most recent of 26 reports, 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 ↗
• 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 ↗
• MalfunctionJul 20, 2023Over-Sensing; Device Sensing Problem; Over-Sensing; Device Sensing Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359140 ↗
• MalfunctionMay 24, 2023Deflation Problem; Low Readings; Deflation Problem; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990394 ↗
• MalfunctionApr 11, 2023Over-Sensing; Low Readings; Over-Sensing; Low Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16711475 ↗
• MalfunctionFeb 17, 2023Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396048 ↗
• MalfunctionFeb 8, 2023False Alarm; Low Readings; False Alarm; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324996 ↗
• MalfunctionJan 5, 2023Low Readings; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102943 ↗
• MalfunctionDec 30, 2022Over-Sensing; Low Readings; Over-Sensing; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076518 ↗
• MalfunctionDec 1, 2022Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PROCEDURE A BUBBLE DETECTOR SENSOR 3/8" MALFUNCTIONED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894316 ↗
• MalfunctionNov 3, 2022Under-Sensing; Under-Sensing

  LIVANOVA RECEIVED REPORT THAT A BUBBLE DETECTOR SENSOR STOPPED SENSING DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723102 ↗
• MalfunctionOct 4, 2022Device Sensing Problem; Device Sensing Problem

  LIVANOVA RECEIVED REPORT OF A BUBBLE DETECTOR SENSOR HAVING BUBBLE ALARM ISSUE DURING PROCEDURE. NO ADDITIONAL DETAIL WAS PROVIDED AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535240 ↗
• MalfunctionSep 19, 2022Device Sensing Problem; Device Sensing Problem

  LIVANOVA RECEIVED REPORT THAT A BUBBLE DETECTOR SENSOR MALFUNCTIONED DURING SETUP. CUSTOMER REQUESTED REPLACEMENT OF THE SENSOR. NO OTHER DETAIL WAS PROVIDED AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446296 ↗
• MalfunctionAug 26, 2022Under-Sensing; Under-Sensing

  LIVANOVA RECEIVED REPORT THAT DURING BYPASS THE PERFUSIONIST NOTICED THAT THE BUBBLE SENSOR SHOWED A YELLOW ¿!¿ ON THE DISPLAY CONTROL PANEL AND WAS NOT READING. A PLENTY OF ULTRASONIC GEL WAS ADDED AND IT WORKED TEMPORARILY BUT THEN GAVE A ¼¿ SYMBOL WITH YELLOW "!". THE BUBBLE SENSOR WAS SET ON LARGE SIZE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071318. One submission often covers many models, so check the product and lot details in each record.

• Z-1119-2020 · Jan 28, 2019 · Terminated
  LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorp
• Z-2866-2016 · Aug 25, 2016 · Terminated
  Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypa
• Z-0856-2014 · Dec 4, 2013 · Terminated
  S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
• Z-0142-2014 · Sep 24, 2013 · Terminated
  S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6)
• Z-0274-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0272-2013 · Sep 19, 2012 · Terminated
  S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0271-2013 · Sep 19, 2012 · Terminated
  S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0275-2013 · Sep 19, 2012 · Terminated
  Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0273-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-1327-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) ho
• Z-1325-2012 · Feb 23, 2012 · Terminated
  S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1326-2012 · Feb 23, 2012 · Terminated
  S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1328-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.