CoughAssist CoughAssist, E70, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959005532), received between Aug 16, 2023 and Dec 26, 2025 — classified as 3 deaths, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025No Display/Image; Failure to Power Up; Smoking; No Display/Image; Failure to Power Up; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING WHEN A PATIENT WAS USING A COUGHASSIST E70 DEVICE, IT STARTED TO RELEASE SMOKE FROM THE BACK, AND THE SCREEN WENT BLACK. THE DEVICE NO LONGER WORKS. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED FOR THE MANUFACTURER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899070 ↗
• DeathSep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALE PATIENT, 52 YEARS OLD WITH A DIAGNOSIS OF ALS, DIED ON (B)(6) 2025, IN THE HOSPITAL IN (B)(6) THERE WAS NO EVIDENCE OF A MALFUNCTION OF THE CA E70 INTERNATIONAL DEVICE. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE COMPLAINT REVIEW HAS DETERMINED THAT DUE TO INSUFFICIENT INFORMATION THIS WILL BE REPORTED. ALTHOUGH THERE IS NOT AN ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED "DEATH". THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 23026983 ↗
• DeathJul 23, 2025No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CA E70 "DISPLAY WAS NOT WORKING". THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. THE DEVICE TO BE SENT BACK WITHOUT EVALUATION BASED ON THE CUSTOMER'S DECISION AS THE END CUSTOMER DIED IN THE MEANTIME. A CLINICAL ASSESSMENT DETERMINED BASED ON AVAILABLE INFORMATION AT THIS TIME, THE ALLEGED HARM DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. A GOOD FAITH EFFORT ATTEMPT WILL BE MADE TO DETERMINE THE CAUSE OF DEATH. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577345 ↗
• MalfunctionMar 28, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A THERMAL COMPLAINT ON A COUGH ASSIST DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING WHIRRING NOISE AND BURNING SMELL COMING FROM THE DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724628 ↗
• DeathDec 19, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE MANUFACTURER RECEIVED INFORMATION THAT A PERSON DIED WHILE USING THE COUGH ASSIST E-70. THE COUGH ASSIST E-70 WAS USED ON THE PATIENT INSTEAD OF A VENTILATOR. THIS EVENT IS A LEGAL MATTER AND IS UNDER INVESTIGATION BY THE POLICE WHO WAS THE INITIAL REPORTER OF THIS EVENT THE POLICE WILL COMMISSION AN EXTERNAL EXPERT FOR AN INVESTIGATION AND STATES THAT IT IS NOT POSSIBLE TO SEND THE DEVICE BACK TO THE MANUFACTURER FOR FURTHER INVESTIGATION AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18361475 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING DURING THE USE OF A COUGH ASSIST DEVICE A PNEUMOTHORAX OCCURRED. THERE WAS NO MEDICAL INTERVENTION REPORTED. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Pneumothorax

  MAUDE report 17557963 ↗