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Wisp Wisp Youth Mask, Fabric, with Magnetic Clips, USRecalls & reported problems

Respironics, Inc. · Wisp Youth Mask, Fabric, with Magnetic Clips, USA · 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 00606959039971), received between Mar 4, 2022 and Mar 4, 2022 — 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.

Most reported problems

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Headache1

Recent adverse event reports

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

  • InjuryMar 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF THREE DAYS OF HEADACHES WHEN USING A WISP YOUTH MASK WITH MAGNETIC CONNECTIONS. THE USER REPORTED TO THE CUSTOMER THAT HE HAD A SHUNT IN HIS HEAD AND IS NOT ALLOWED TO HAVE ANY METAL OR MAGNETS NEAR IT. THE USER STOPPED USING THE WISP MASK WITH MAGNETS AND THE HEADACHES WENT AWAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MASK WAS NOT RETURNED FOR INVESTIGATION DESPITE REQUESTS FOR PRODUCT. THE WISP YOUTH NASAL MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS 7 YEARS OR OLDER (>40 LBS/18 KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE WISP INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRI

    Patient problems: Headache

    MAUDE report 13666052 ↗

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Sources and updates

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