Newport HT70M-WW-NA (UDI 10884521544062)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521544062), received between Jun 29, 2017 and Sep 12, 2018 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 12, 2018Failure to Deliver; Failure to Deliver

  THE LITIGATION COMPLAINT PROVIDED TO MEDTRONIC ON AUGUST 23, 2018 REPORTED THAT ON OR ABOUT (B)(6) 2016, A PATIENT AT (B)(6) WAS USING A MEDTRONIC HT70 VENTILATOR AND THE PATIENT¿S ENDOTRACHEAL TUBE BECAME DISLODGED. IT WAS FURTHER REPORTED THAT THE PATIENT WENT INTO HYPOXIC ISCHEMIC ENCEPHALOPATHY, WAS TRANSFERRED TO (B)(6) AND PASSED AWAY ON (B)(6) 2016. THE VENTILATOR HAS NOT BEEN PROVIDED TO MEDTRONIC FOR EVALUATION. ALTHOUGH THERE IS NO ALLEGATION OF THE PRODUCT MALFUNCTIONING, THIS EVENT IS BEING CONSERVATIVELY REPORTED DUE TO A PATIENT DEATH.

  Patient problems: Death

  MAUDE report 7871189 ↗
• MalfunctionJun 29, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING TESTING AN HT70 VENTILATOR DATE AND TIME WAS CONSISTENTLY RESETTING TO DEFAULT SETTINGS. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE COIN BATTERY. THE VENTILATOR PASSES ALL TESTS, CALIBRATIONS AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6677474 ↗

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