Invacare® ContourU® Naked Back CM02BRecalls & reported problems

Invacare Corporation · ContourU Naked Back · 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 00841447102878), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Patient-Device Incompatibility1

Patient problems

Pressure Sore/Ulcer1

Recent adverse event reports

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

InjurySep 18, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
THE DEALER REPORTED THAT THE CONTOUR SEATING SYSTEM WAS TOO TIGHT ON THE RIGHT SIDE AND CAUSED AN OPEN SORE ON THE RIGHT SIDE OF THE PATIENT'S BACK. THE PATIENT ALREADY HAS NURSES CARING FOR HER 16 HOURS EVERY DAY, AND THEY ARE TREATING THE SORE.
Patient problems: Pressure Sore/Ulcer
MAUDE report 20251255 ↗

Device details

UDI-DI	`00841447102878`
Brand	Invacare® ContourU® Naked Back
Model	CM02B
Company	Invacare Corporation
Product code	IMP · CUSHION, WHEELCHAIR
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2026

Device type (GMDN): Wheelchair seat cushion

A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

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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.

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