Newport HT70M-JP-NA (UDI 10884521542075)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884521542075), received between Aug 18, 2017 and Oct 16, 2025 — classified as 1 injury, 88 malfunctions.

The most frequently reported specific device problem is “No Flow” (66 reports).

4 other recalls cover devices cleared under the same FDA submission (K111146); 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 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A CONTINUOUS ALARM AND VENTILATION STOPPED. IT WAS ALSO REPORTED THAT THE UNIT HAD NO DISPLAY ON THE SCREEN AND THE UNIT COULD NOT BE RESTARTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS MANUALLY VENTILATED VIA AN AMBU BAG WITHOUT INJURY. REVIEW OF THE VENTILATOR LOGS CONFIRMED REPORTED VENTILATOR SHUTDOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316553 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN ALARM "HARDLY SOUNDED" ON THIS HT70 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172550 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING BY MEDTRONIC SERVICE PERSONNEL, THIS HT70 VENTILATOR WAS NOTED TO HAVE A SHUT DOWN BUZZER ALARM TEST FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168135 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN ALARM OF THIS HT70 VENTILATOR "ALMOST" DID NOT SOUND WHEN THE POWER WAS TURNED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167848 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THIS HT70 VENTILATOR WAS NOTED TO HAVE A SHUTDOWN ALARM THAT HARDLY SOUNDED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167680 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN ALARM OF THIS HT70 VENTILATOR "HARDLY SOUNDED" WHEN THE POWER WAS TURNED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167495 ↗
• MalfunctionJun 9, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, IT WAS OBSERVED THAT THE SHUTDOWN ALARM OF THIS HT70 VENTILATOR BARELY SOUNDED WHEN THE POWER WAS TURNED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167386 ↗
• MalfunctionJun 7, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE GENERATED SHUTDOWN ALARM OF THIS HT70 VENTILATOR WAS SHORT. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163162 ↗
• MalfunctionJun 7, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN ALARM GENERATED BY THIS HT70 VENTILATOR SOUNDED IN "SHORT TIME" WHEN THE UNIT WAS POWERED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162380 ↗
• MalfunctionJun 6, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE HT70 VENTILATOR'S SHUTDOWN ALARM WAS OBSERVED TO BE TOO SHORT. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161844 ↗
• MalfunctionJun 6, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN ALARM OF THIS HT70 VENTILATOR BARELY SOUNDED WHEN THE POWER WAS TURNED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161590 ↗
• MalfunctionJun 6, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, IT WAS OBSERVED THAT THE SHUTDOWN ALARM HARDLY SOUNDED ON THIS HT70 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161417 ↗
• MalfunctionJun 5, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED AN ABNORMAL ALARM THEN UNIT SHUT DOWN AND THE VENTILATION STOPPED.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155118 ↗
• MalfunctionMay 15, 2025No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR WOULD NOT START. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032097 ↗
• MalfunctionMar 26, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A SHUTDOWN ALARM WITH A LOW SOUND, FOLLOWED BY A SYSTEM ERROR DISPLAYED ON THE SCREEN. ALTHOUGH THE UNIT'S SCREEN REMAINED OPERATIONAL, THE VENTILATION STOPPED, AND WAS NOT ABLE TO PERFORM VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701167 ↗
• MalfunctionMar 19, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR WAS CONTINUOUSLY GENERATING A SHUTDOWN ALARM, THE SCREEN DISPLAYED A SYSTEM ERROR, APPEARED THAT NO AIR WAS BEING AND THE PATIENT'S OXYGEN (O2) SATURATION DROPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21649046 ↗
• MalfunctionMar 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE SCREEN OF THIS HT70 VENTILATOR WAS FROZEN, THE UNIT GENERATED AN "OPERATIONAL MALFUNCTION" ALARM AND THE VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY. A REVIEW OF THE VENTILATOR LOGS CONFIRM THE REPORTED LOSS OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587286 ↗
• MalfunctionMar 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A SHUTDOWN ALARM AND THE VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586730 ↗
• MalfunctionFeb 25, 2025No Flow; No Flow

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A SYSTEM ERROR ALARM AND THE VENTILATION STOPPED WHILE THE PATIENT WAS CONNECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461036 ↗
• MalfunctionFeb 13, 2025Defective Alarm; No Flow; Pressure Problem; Defective Alarm; No Flow; Pressure Problem

  IT WAS REPORTED THAT DURING A POSITION CHANGE, THE PEAK AIRWAY PRESSURE OF THIS HT70 VENTILATOR WAS LOWER THAN USUAL, NO ALARM SOUND WAS GENERATED AND THE UNIT STOPPED VENTILATING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379782 ↗
• MalfunctionJan 8, 2025No Flow; No Flow

  UPDATED: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR ALARMED AND GENERATED A SYSTEM ERROR MESSAGE AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107343 ↗
• MalfunctionOct 14, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATION STOPPED ON THIS HT70 VENTILATOR AND IT COULD NOT BE ACTIVATED AND THE UNIT ALSO GENERATED AND DISPLAYED A "SYSTEM ERROR" MESSAGE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447306 ↗
• MalfunctionAug 14, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE GRAPHICAL USER INTERFACE OF THIS HT70 VENTILATOR FROZE AND VENTILATION STOPPED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986610 ↗
• MalfunctionMar 26, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATION SUDDENLY STOPPED ON THIS HT70 VENTILATOR AND THE UNIT SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980578 ↗
• MalfunctionJan 26, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A SHUTDOWN ALARM, THE UNIT SCREEN WENT OFF AND THE VENTILATION STOPPED WHILE THE PATIENT WAS CONNECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111146. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2025 · May 21, 2025 · Open, Classified
  Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU
• Z-1874-2017 · Mar 30, 2017 · Terminated
  Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure
• Z-1171-2013 · Apr 5, 2013 · Terminated
  Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide
• Z-2250-2012 · Aug 3, 2012 · Terminated
  Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pre