Handicare 341610Recalls & reported problems

Handicare USA, Inc. · Independent Lifter - Medium Leg Support · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810045511504), received between Jun 21, 2024 and Sep 15, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Fell2
Adverse Event Without Identified Device or Use Problem1
Use of Device Problem1

Patient problems

Bone Fracture(s)1
Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjurySep 15, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A LEG SPASM AND FELL FROM INDEPENDENT LIFTER WHILE USING WITHOUT ASSISTANCE, SUSTAINING A LEG FRACTURE. ACCORDING TO THE PATIENT AND ONSITE INVESTIGATION, THERE WAS NO DEVICE MALFUNCTION.
Patient problems: Bone Fracture(s)
MAUDE report 23057995 ↗
MalfunctionSep 13, 2024Device Fell; Device Fell
INDEPENDENT LIFTER SPRING BROKE, CAUSING PATIENT TO FALL FROM LIFTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20217298 ↗
MalfunctionJun 21, 2024Device Fell; Device Fell
INDEPENDENT LIFTER SPRING BROKE, CAUSING PATIENT TO FALL FROM LIFTER.
Patient problems: Insufficient Information
MAUDE report 19581074 ↗

Device details

UDI-DI	`00810045511504`
Brand	Handicare
Model	341610
Company	Handicare USA, Inc.
Product code	INE · Sling, Overhead Suspension, Wheelchair
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 23, 2024

Device type (GMDN): General-purpose patient lifting system sling/harness

A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

Other Sling, Overhead Suspension, Wheelchair devices

Handicare 547810
Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair
2 reports
Handicare 400032
Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair
1 report

All Sling, Overhead Suspension, Wheelchair devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.