Mölnlycke® Z-Flex™ Fluidized Heel Boot 1400123Recalls & reported problems

Mölnlycke Health Care AB · Fluidized Heel Boot · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07323190250554), received between Mar 24, 2026 and Mar 24, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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.

Reports received per month

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

Most reported problems

Device problems

Human-Device Interface Problem1
Insufficient Device Problem Information1

Patient problems

Blister1
Skin Erosion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMar 24, 2026Human-Device Interface Problem; Insufficient Device Problem Information
WE RECEIVED A REPORT OF A PATIENT DEVELOPING DEEP TISSUE INJURIES (DTIS) WHILE THE DEVICE WAS BEING USED AS INTENDED TO HELP REDUCE THE RISK OF PRESSURE RELATED INJURIES. ACCORDING TO THE REPORTER, THE AFFECTED PATIENT DEVELOPED LOCALIZED AREAS OF DISCOLORATION AND TISSUE BREAKDOWN CONSISTENT WITH SUSPECTED DTIS. THE DTIS WERE IDENTIFIED DURING ROUTINE CLINICAL ASSESSMENT.AT THE TIME OF REPORTING, LIMITED CLINICAL DETAILS WERE AVAILABLE REGARDING THE EXACT ONSET, PROGRESSION, AND CONTRIBUTING MEDICAL CONDITIONS. NO DEFINITIVE DEVICE MALFUNCTION HAS BEEN CONFIRMED. HOWEVER, BECAUSE DTIS REPRESENT A SERIOUS INJURY AND THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE INJURY DURING NORMAL USE, THIS EVENT MEETS THE CRITERIA FOR REPORTING UNDER 21 CFR PART 803.AN INVESTIGATION HAS BEEN INITIATED. WE ARE CONDUCTING A REVIEW OF DEVICE HISTORY RECORDS, COMPLAINT TRENDS, RISK MANAGEMENT DOCUMENTATION, AND ANY AVAILABLE PRODUCT RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER TO CLARIFY THE CLINICAL CIRCUMSTANCES, DEVICE USAGE CONDITIONS, AND ANY POTENTIAL CONFOUNDING PATIENT FACTORS (E.G., COMORBIDITIES, MOBILITY
Patient problems: Blister; Skin Erosion
MAUDE report 24680292 ↗

Device details

UDI-DI	`07323190250554`
Brand	Mölnlycke® Z-Flex™ Fluidized Heel Boot
Model	1400123
Company	Mölnlycke Health Care AB
Product code	FMP · Protector, skin pressure
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	Dec 21, 2022

Device type (GMDN): Foot friction/impact protector

A device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.

Other Protector, skin pressure devices

Sage Air Tap LC 7287
Sage Products, LLC · Protector, skin pressure
3 reports
Arthrex AR-1650-01
Allen Medical Systems, Inc. · Protector, skin pressure
2 reports
Arthrex® AR-1650-02
Arthrex, Inc. · Protector, skin pressure
1 report
Gel Corn Pads, Black, One Size, Bulk 31705
Silipos Holding LLC · Protector, Skin Pressure
1 report

All Protector, skin pressure devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page