Wisp 00Recalls & reported problems
Respironics, Inc. · WispDreamWisp Magnetic Clips, Replacement Part · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959039698), received between Jul 15, 2022 and Jul 15, 2022 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2022Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility
THE MANUFACTURER RECEIVED INFORMATION THAT AN END USER EXPERIENCED IRREGULAR BLOOD PRESSURE AFTER WEARING THE WISP MASK WITH MAGNETIC CONNECTIONS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. 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, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC HEADGEAR CLIPS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL SWALLOWING, SEEK MEDICAL ASSISTANCE IMMEDIATELY. THIS REPORT WILL BE FILED AS AN INITIAL-FINAL REPORT. WE WILL CONTINUE TO MONITOR THESE COMPLAINTS REGARDING MAGNETS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, AN ADDITIONAL REPORT WILL BE FILED. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT TH
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 15027518 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.