Doc Band® CRANIALHELMETRecalls & reported problems

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 B288CRANIALHELMET0), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 injury.

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

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Hematoma1
Skull Fracture1

Recent adverse event reports

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

InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHY PATIENT (MINOR) WAS IN TREATMENT WITH CRANIAL ORTHOSIS FOR 3 MONTHS. DURING THE TREATMENT PERIOD, BABY SUFFERED AN INJURY TO THE NOSE CAUSING A BLOOD CLOT (SEPTAL HEMATOMA) REQUIRING SURGERY. MOM DISCLOSED DURING THE NEXT APPOINTMENT THAT BABY HAD SURGERY TO ADDRESS THE INJURY ON (B)(6) 2020. DURING THIS APPOINTMENT, AN ADJUSTMENT WAS MADE TO THE FRONT OF THE BAND TO KEEP IT FROM IRRITATING THE SURGICAL AREA. PATIENT HAD TWO WEEKS OF TREATMENT LEFT AT THIS POINT, BUT PARENTS CANCELED THE EXIT APPOINTMENT. ALMOST 5 WEEKS LATER, PARENTS SCHEDULED AND CAME IN FOR AN EXIT APPOINTMENT ON (B)(6) 2020. DURING THIS APPOINTMENT, PARENTS REPORTED THAT THE BABY HAD BROKEN HIS NOSE AND HAD A SEPTAL HEMATOMA (RATHER THAN WHAT WAS INITIALLY REPORTED AS A BLOOD CLOT). THOUGH THEY (PARENTS) DID NOT SEE THE INJURY OCCUR, THEIR ENT FELT THAT THE BAND CAUSED THE INJURY. SINCE THE INJURY/EVENT WAS NOT OBSERVED, AND NO INJURY WAS EXTERNALLY NOTICEABLE OR IDENTIFIED FOR SEVERAL DAYS, IT IS NOT CLEAR EXACTLY WHEN THE INJURY OCCURRED. AS A RESULT, IT IS NOT CLEAR AT THIS POINT WHETHER THE CRANIAL ORTHOSIS WAS INVOLVED IN CAUSING THE INJURY.
Patient problems: Hematoma; Skull Fracture
MAUDE report 11032959 ↗

Device details

UDI-DI	`B288CRANIALHELMET0`
Brand	Doc Band®
Model	CRANIALHELMET
Company	Cranial Technologies, Inc.
Product code	MVA · Orthosis, Cranial
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 5, 2026

Device type (GMDN): Cranial orthosis

A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

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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