Aquasence 770-420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00754021215928), received between Feb 24, 2022 and Dec 3, 2025 — classified as 1 injury, 1 malfunction.

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

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.

• InjuryDec 3, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BOARD BY THE PROVIDER WHO REPORTED THE BATH BOARD COLLAPSED WHILE IN USE. THE END USER FELL AND WAS ADMITTED TO THE HOSPITAL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Fall

  MAUDE report 23707593 ↗
• MalfunctionFeb 24, 2022Collapse

  END USER FELL IN THE BATH TUB WHILE USING THE UNIT AND SUFFERED SOME MINOR BRUISING. THE UNIT COLLAPSED CAUSING HER TO FALL INTO THE TUB WHILE UNDER SUPERVISION OF HER CAREGIVER. SHE SOUGHT NO MEDICAL ATTENTION BECAUSE THE CAREGIVER WAS THERE TO HELP, BUT SHE IS SORE AND BRUISED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE TIGHTENING MECHANISM SPLIT.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 13595244 ↗