WISP Wisp Mask, Clear Frame, with magnetic clips, USRecalls & reported problems

Respironics, Inc. · Wisp Mask, Clear Frame, with magnetic clips, US · Class 2

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 00606959006836), received between May 5, 2025 and May 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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

Patient Device Interaction Problem1

Patient problems

Hydrocephalus1

Recent adverse event reports

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

InjuryMay 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WAS INJURED THROUGH THE USE OF A WISP NASAL MASK WITH MAGNETS WHEN IT INTERFERED WITH AN IMPLANTED SHUNT AND CAUSED HYDROCEPHALUS. THE PATIENT WAS SOLD A WISP NASAL MASK ON (B)(6) 2022, AND ONCE HE STARTED USING THE MASK, HIS VENTRICULOPERITONEAL SHUNT (VPS) STARTED RESETTING TO A LOWER VALUE, CAUSING HYDROCEPHALUS. THE PATIENT STATED THEY DISCOVERED THAT THE MASK WAS IMPACTING THEM ON (B)(6) 2023, WHEN THE DOCTOR REPLACED THE STRATA II VALVE OF VPS DUE TO IT HAVING TO BE RESET MULTIPLE TIMES AND THE SHUNT WAS STILL MALFUNCTIONING. DESPITE HAVING OPEN BRAIN SURGERY TO REPLACE THE VALVE, THE SHUNT CONTINUED MALFUNCTIONING. THE PATIENT WAS ADVISED BY HIS DOCTOR TO GET A MAGNET DETECTOR, AND HE FOUND A MAGNET WITHIN THE MASK. IT WAS REPORTED THAT THE MASK DID NOT HAVE THE FDA WARNING REGARDING THE MAGNETIC CLIPS THAT WAS ISSUED IN (B)(6) OF 2022 NOR WAS THE PATIENT NOTIFIED THAT THE MAGNETIC CLIPS COULD IMPACT SHUNTS. THE MASK HAS NOT YET BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Hydrocephalus
MAUDE report 21961185 ↗

Device details

UDI-DI	`00606959006836`
Brand	WISP
Model	Wisp Mask, Clear Frame, with magnetic clips, US
Catalog no.	1094050
Company	Respironics, Inc.
Product code	BZD · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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	In Commercial Distribution
Record updated	Oct 14, 2024

Device type (GMDN): CPAP/BPAP nasal mask, reusable

A flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

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All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) 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.

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