PowerHickman 0805810Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741036668), received between Dec 26, 2022 and Aug 12, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 reports).

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE HAD ALLEGEDLY ISSUES WITH CUFF DETACHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED, CUFF STAYED IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959848 ↗
• MalfunctionAug 12, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD ISSUES WITH CUFF DETACHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED, CUFF STAYED IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959847 ↗
• MalfunctionAug 12, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE HAD ALLEGEDLY ISSUES WITH CUFF DETACHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED, CUFF STAYED IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959843 ↗
• MalfunctionAug 4, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF WAS ALLEGEDLY FOUND TO BE LOOSENED UPON REMOVAL OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND THE CUFF HAD ALLEGEDLY STAYED IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903467 ↗
• MalfunctionApr 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE CUFF WAS ALLEGEDLY SLIDING UP AND DOWN. IT WAS FURTHER REPORTED THAT THE CUFF ALLEGEDLY FAILED TO ADHERE TO THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017468 ↗
• MalfunctionJun 21, 2023Fracture; Material Separation; Stretched; Fracture; Material Separation; Stretched

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY CAME APART. THE PROCEDURE WAS COMPETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169516 ↗
• MalfunctionMay 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, DURING REMOVAL OF THE CATHETER, THE CUFF ALLEGEDLY REMAINED IN PLACE WHICH REQUIRED SURGICAL REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16851366 ↗
• MalfunctionDec 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FOUR MONTHS THIRTY DAYS POST CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY DETACHED AND REMAINED INSIDE THE PATIENT FOLLOWING THE DEVICE CATHETER REMOVAL PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046535 ↗