Wisp 1118066Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959051928), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 death.

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

Recent adverse event reports

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

• DeathNov 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN END USER'S PACEMAKER FAILED AND THE PATIENT EXPIRED WHILE USING THE WISP MASK WITH MAGNETIC CONNECTIONS. THE ACTUAL DATE OF DEATH IS UNKNOWN. THE USER ALLEGEDLY HAD THE PACEMAKER FOR 2 MONTHS WHEN HE STARTED HAVING DIFFICULTY BREATHING, HYPOXEMIA, AND ATRIAL FIBRILLATION. THE USER'S SPOUSE STATED HE WAS AWAKE AND SITTING ON THE COUCH WHEN THE PACEMAKER FAILED AND WAS NOT WEARING THE MASK AT THE TIME. THE SPOUSE STATED SHE BELIEVES THE MAGNETS WERE LESS THAN 2 INCHES FROM THE PACEMAKER WHEN THE MASK WAS WORN BECAUSE HER HUSBAND WOULD SLEEP WITH HIS HEAD AND CHIN DOWN ON HIS SHOULDER AND SHE THINKS THE MAGNETS WERE DOWN ON HIS SHOULDER. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: Atrial Fibrillation; Dyspnea; Low Oxygen Saturation

  MAUDE report 15772995 ↗