Apollo 8606500Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 04048675229674), received between Apr 25, 2017 and Aug 18, 2026 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (73 reports).

2 other recalls cover devices cleared under the same FDA submission (K042607); 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Gas Output Problem; Failure to Deliver; Protective Measures Problem

  It was reported that the device posted a "Ventilator Failure" alarm during use. There was no injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50294193 ↗
• MalfunctionMay 6, 2026Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THERE WAS A VENT FAIL DURING USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093706 ↗
• MalfunctionApr 16, 2026Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE DEVICE HAD A VENT FAIL ERROR. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893307 ↗
• MalfunctionApr 9, 2026Gas Output Problem; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A CASE WHICH HAD OCCURRED ON (B)(6) 2026 AT 8:15AM, THE DEVICE SUDDENLY HAD A VENTILATOR FAILURE AND SWITCHED TO MANUAL MODE. THE HOSPITAL BIOMED HAS NOT BEEN ABLE TO DUPLICATE THE REPORTED ISSUE. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827246 ↗
• MalfunctionDec 15, 2025Decrease in Pressure; Insufficient Flow or Under Infusion; Inaccurate Delivery; Gas/Air Leak; Decrease in Pressure; Insufficient Flow or Under Infusion; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT THE MECHANICAL VENTILATOR DIDN'T SEEM TO BE VENTILATING AS PER WHAT CLINICIAN EXPECTED BASED ON SETTINGS. THEY WERE ABLE TO BAG THE PATIENT WITHOUT ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801274 ↗
• MalfunctionDec 15, 2025Degraded; Gas Output Problem; Failure to Deliver; No Pressure; Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT DURING USE (IMMEDIATELY AFTER ANESTHESIA INDUCTION), A VENTILATOR MALFUNCTION OCCURRED, AND THE DEVICE WAS REPLACED WHILE MANUAL VENTILATION WAS PERFORMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801258 ↗
• MalfunctionDec 1, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT THE UNIT'S DISPLAY WENT BLANK DURING CASE. THE DISPLAY WENT ALL WHITE, THEN DISPLAY CAME BACK, BUT ENDED WITH A VENTILATOR FAILURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678880 ↗
• MalfunctionNov 27, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE APOLLO POSTED A VENTILATOR FAILURE DURING USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666248 ↗
• MalfunctionSep 16, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THERE WAS A VENT FAIL DURING A CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061303 ↗
• MalfunctionSep 5, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT AUTOMATIC VENTILATION FAILED DURING USE OF THE DEVICE. IT WAS LATER CONFIRMED TO DRÄGER THAT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976059 ↗
• MalfunctionJul 31, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN AUTOMATIC VENTILATION DURING USE WHILE POSTING A CORRESPONDING ALARM. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673701 ↗
• MalfunctionJul 30, 2025Intermittent Continuity; Gas Output Problem; Insufficient Flow or Under Infusion; Failure to Deliver; Intermittent Continuity; Gas Output Problem; Insufficient Flow or Under Infusion; Failure to Deliver

  IT WAS REPORTED THAT SYSTEM FAILED DURING CASE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661599 ↗
• MalfunctionJul 4, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING DURING A CASE. THEY REBOOTED THE UNIT AND IT STARTED WORKING AGAIN. THE CASE WAS FINISHED. NO REPORTED PATIENT INJURY. THE DEVICE HAS NO UDI AS AN UDI WAS NOT REQUIRED AT THE TIME THE DEVICE WAS MANUFACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402919 ↗
• MalfunctionJun 5, 2025Gas Output Problem; Improper Flow or Infusion; Pressure Problem; Gas Output Problem; Improper Flow or Infusion; Pressure Problem

  A VENTILATOR FAILURE WAS REPORTED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148711 ↗
• MalfunctionApr 28, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE OF THE DEVICE. THE TEAM REPORTEDLY FINISHED THE SURGERY IN MANUAL VENTILATION; NO HEALTH CONSEQUENCES FOR THE PATIENT WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917724 ↗
• MalfunctionApr 28, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE OF THE DEVICE. THE TEAM REPORTEDLY FINISHED THE SURGERY IN MANUAL VENTILATION; NO HEALTH CONSEQUENCES FOR THE PATIENT WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917010 ↗
• MalfunctionMar 26, 2025Degraded; Gas Output Problem; Failure to Deliver; No Pressure; Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT ON (B)(6) 2025 A VENTILATOR MALFUNCTION OCCURRED DURING SURGERY AND MECHANICAL VENTILATION WAS STOPPED. MANUAL VENTILATION WAS SUBSTITUTED AND SURGERY CONTINUED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695996 ↗
• MalfunctionMar 20, 2025Intermittent Continuity; Gas Output Problem; Failure to Deliver; Intermittent Continuity; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE UNIT FAILED ON A PATIENT WITH VENTILATOR FAILURE. THEY HAD TO BAG PATIENT TO FINISH. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650255 ↗
• MalfunctionFeb 28, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT THE UNIT FAILED AT THE END OF CASE WITH A VENTILATOR FAILURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21489717 ↗
• MalfunctionJan 17, 2025Failure to Deliver; Output Problem; Failure to Deliver; Output Problem

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE OF THE DEVICE. MECHANICAL VENTILATION WAS NO LONGER POSSIBLE. IT WAS SWITCHED TO MANUAL VENTILATION. AFTER RESTART OF THE ANESTHESIA DEVICE THE SURGERY WAS CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176434 ↗
• MalfunctionDec 18, 2024Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  REPORTEDLY MECHANICAL VENTILATION CEASED DURING USE. THE DEVICE POSTED A CORRESPONDING ALARM. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20964261 ↗
• MalfunctionOct 24, 2024Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  VENT FAIL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521108 ↗
• MalfunctionSep 18, 2024Intermittent Continuity; Gas Output Problem; Failure to Deliver; Pressure Problem; Intermittent Continuity; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE APOLLO HAD A VENTILATOR FAILURE IN THE MIDDLE OF A CASE. THERE WAS NO PATIENT HARM DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244264 ↗
• MalfunctionSep 18, 2024Intermittent Continuity; Gas Output Problem; Failure to Deliver; Pressure Problem; Intermittent Continuity; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT APOLLO ASNC-0001 HAD ANOTHER VENT FAIL DURING USE. THERE WAS NO PATIENT HARM DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244262 ↗
• MalfunctionJul 23, 2024Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE UNIT DISPLAYED AN ALARM CHECK VENTILATOR ASSEMBLY DURING CASE AND STARTED HAVING LEAKAGE ISSUES. NO INJURY WAS REPORTED. DURING INVESTIGATION THIS CASE WAS FOUND TO BE REPORTABLE, OTHER THAN INITIALLY ASSUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805102 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042607. One submission often covers many models, so check the product and lot details in each record.

• Z-1955-2009 · Jul 17, 2009 · Terminated
  Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
• Z-0087-2009 · Aug 22, 2008 · Terminated
  Draeger Medical Apollo Anesthesia Machine, catalog number 8606500