POWERWAND (ED) 3 Fr X 6 cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10859821006527), received between Oct 16, 2018 and Oct 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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

Recent adverse event reports

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

• InjuryOct 16, 2018Material Fragmentation; Difficult to Remove; Material Deformation

  THE FLOOR NURSE ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT'S ARM. DURING THE CATHETER REMOVAL PROCESS, THE NURSE REPORTED THAT IT WAS DIFFICULT AND THAT THE PATIENT APPEARED TO BE IN PAIN. UPON REMOVAL OF THE CATHETER FROM THE PATIENT'S ARM, THE NURSE OBSERVED AN UNKNOWN ANGLE TO THE CATHETER TIP. THE INCIDENT WAS DISCUSSED AMONG THE HOSPITAL BOARD AND THEY SUSPECT THE INCIDENT WAS DUE TO USER ERROR. FURTHERMORE, AN XRAY WAS TAKEN ON THE PATIENT'S ARM AND IT APPEARED THAT REMNANTS OF THE CATHETER REMAINED IN THE PATIENT'S ARM. THE HOSPITAL CONTINUED TO MONITOR THE PATIENT'S CURRENT CONDITION AND INTERVENTION WAS NOT CONFIRMED.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 7970410 ↗