Wisp Wisp Mask, Small-Medium, Clear Frame, w/Headgear, INTLRecalls & reported problems
Respironics, Inc. · Wisp Mask, with Clear Frame, with Headgear, Small-Medium, International · Class 2
Data updated Oct 16, 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 00606959040021), received between Jun 8, 2020 and Jun 8, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Cancer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER BECAME AWARE THAT A USER ALLEGES, ACCORDING TO HER PHYSICIAN, USAGE OF A MASK CAUSED HER TO DEVELOP SKIN CANCER ON HER FACE. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE MANUFACTURER HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FOR ADDITIONAL INFORMATION AND FOR RETURN OF THE MASK. NO FURTHER COMMUNICATION HAS BEEN RECEIVED FROM THE USER, AND NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. THE WISP MASK MEETS ALL RELEVANT STANDARDS FOR BIO-COMPATIBILITY. THE USER IS WARNED "SOME USERS MAY EXPERIENCE SKIN REDNESS, IRRITATION, OR DISCOMFORT. IF THIS HAPPENS, DISCONTINUE USE AND CONTACT YOUR HEALTHCARE PROFESSIONAL." BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER IS UNABLE TO CONFIRM THE MASK CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: Cancer
MAUDE report 10129014 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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