HealthSmart 522-1508-1901Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00041298991496), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Unintended Movement; Unintended Movement

  INJURY SUFFERED BY THE CX WHEN THEY USED THE ITEM THEY SUFFERED FRACTURES AND WAS RUSH TO THE HOSPITAL WHEN IT SLIPPED AWAY WHILE SHE'S USING IT THEY SENT THEY SENT US AN EMAIL WE SENT DOCUMENTATION TO THEM THEN THEY ASKED ME FOR THE HOSPITAL DEALS AT THAT TIME I WAS LIKE THEY HAVE NOT SENT ME DEALS ON THE HOSPITAL BECAUSE I WAS STILL GOING THROUGH TREATMENT GOING FOR PHYSICAL THERAPY SO I TOLD THEM I DIDN'T HAVE A YET BUT I GAVE THEM THE NAME OF THE HOSPITAL GAVE THEM EVERYTHING GAVE THEM FOR THE DOCTOR SAID BUT I JUST DID NOT HAVE ANY DEAL TO SEND AND THEN I WENT TO THE HOSPITAL WHEN I GOT TO THE EMERGENCY THEY SAID THAT I UH SUFFER THE FRACTURE AFTER DOING THE X]

  Patient problems: Bone Fracture(s)

  MAUDE report 19972976 ↗