PowerHickman 0805815Recalls & reported problems
Bard Access Systems, Inc. · PowerHickman 8F Single-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff (5cm) Microintroducer Kit · Class 2 · Implant
All models of PowerHickman (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741036675), received between Feb 22, 2018 and Jul 18, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Loss of or Failure to Bond3
- Material Separation3
- Difficult to Remove2
- Device Damaged Prior to Use1
- Device Operates Differently Than Expected1
- Entrapment of Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement2
- Foreign Body In Patient1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25865839 ↗InjuryAug 16, 2024Loss of or Failure to Bond; Difficult to Remove; Material Separation; Loss of or Failure to Bond; Difficult to Remove; Material Separation
IT WAS REPORTED THAT TWO MONTHS AND EIGHTEEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE CUFF ON THE CATHETER ALLEGEDLY CAME OFF WHILE REMOVING THE CATHETER. IT WAS FURTHER REPORTED THAT THE CUFF WAS UNABLE TO BE RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 19998154 ↗MalfunctionAug 13, 2024Loss of or Failure to Bond; Entrapment of Device; Difficult to Remove; Material Separation; Loss of or Failure to Bond; Entrapment of Device; Difficult to Remove; Material Separation
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY REMOVED WHILE THE CUFF REMAINED INTACT UNDERNEATH THE TUNNELED PORTION OF THE SKIN. IT WAS FURTHER REPORTED THAT THE CUFF HAS BEEN REMOVED FROM THE CATHETER AND WAS NOTED TO BE STUCK IN THE PATIENT'S SKIN. REPORTEDLY, THE CUFF NEEDED TO BE DISSECTED OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19969394 ↗MalfunctionMay 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE WHITE CUFF WAS ALLEGEDLY MOBILE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371974 ↗MalfunctionDec 29, 2023Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
IT WAS REPORTED THAT SOMETIMES POST A CATHETER PLACEMENT, THE TIP OF THE CATHETER ALLEGEDLY BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18417593 ↗MalfunctionApr 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT PROCEDURE, THE TUBING WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14217103 ↗MalfunctionJul 23, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE DEVICE PACKAGING HAS AN ALLEGED CUT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7711725 ↗MalfunctionApr 17, 2018Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PATIENT HAS A POWERHICKMAN AND SHE IS HAVING PAIN ALONG WITH DIFFICULTY OBTAINING BLOOD RETURN AT TIMES. SHE REPORTS NOT USING HEPARIN TO LOCK THE CATHETER SHE ALSO REPORTS THAT THE CLAMP IS TOO BULKY. MS&S EXPLAINED THAT THE POWERHICKMAN CVC IS AN OPEN ENDED CATHETER AND THAT IT IS RECOMMENDED TO LOCK THE CATHETER WITH HEPARIN ONCE DAILY TO WEEKLY TO PREVENT COMPLICATIONS. MS&S DISCUSSED CAUSES OF ONE WAY OCCLUSIONS AND RECOMMENDED THAT SHE SPEAK WITH HER PHYSICIAN ABOUT ADMINISTRATION OF CATHFLO OR A DYE STUDY TO CHECK CATHETER FUNCTION.
Patient problems: Pain
MAUDE report 7438649 ↗MalfunctionFeb 22, 2018Kinked; Device Damaged Prior to Use
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE KINKED INSIDE THE PACKAGE. DEVICE WAS NOT USED ON PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7289642 ↗
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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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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