PowerHickman 0805915Recalls & reported problems
Bard Access Systems, Inc. · PowerHickman 9.5F Dual-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
- 12
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741036699), received between Feb 16, 2018 and Jan 2, 2026 — classified as 2 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress3
- Difficult or Delayed Separation3
- Fluid/Blood Leak2
- Material Separation2
- Suction Problem2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient2
- Unspecified Infection2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE THROUGH THE POWERHICKMAN CENTRAL VENOUS CATHETER, IT WAS OBSERVED THAT WHILE FOLLOWING THE PROCEDURE, A PATIENT REPORTEDLY DEVELOPED AN INFECTION, AND THE DEVICE WAS NOTED TO BE OCCLUDED. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23941268 ↗MalfunctionNov 4, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER PLACEMENT PROCEDURE, THERE WAS NO NUMBERS ON THE CATHETER TO MEASURE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20596672 ↗InjuryJun 17, 2024Fluid/Blood Leak; Difficult to Flush; Fracture; Material Puncture/Hole; Suction Problem; Deformation Due to Compressive Stress; Fluid/Blood Leak; Difficult to Flush; Fracture; Material Puncture/Hole; Suction Problem; Deformation Due to Compressive Stress
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE LINE CLAMPS APPEARED TO HAVE WEAKENED THE TUBING OVER TIME AND ALLEGEDLY CREATED A KINK IN THE LINE. IT WAS FURTHER REPORTED THAT THE STRENGTH OF THE TUBING WAS COMPROMISED AND A HOLE HAD ALLEGEDLY OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 19545403 ↗MalfunctionMay 4, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE VALVE WAS NOT ALLEGEDLY SPLIT PROPERLY. THE UNIT WAS PLACED INTO THE PATIENT BUT A PORTION OF THE AREA WAS CUT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866276 ↗MalfunctionMay 4, 2023Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE VALVE WAS NOT ALLEGEDLY SPLIT PROPERLY. IT WAS FURTHER REPORTED THAT THE UNIT WAS PLACED INTO THE PATIENT BUT A PORTION OF THE AREA WAS CUT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866237 ↗MalfunctionMay 4, 2023Material Separation; Deformation Due to Compressive Stress; Difficult or Delayed Separation; Material Separation; Deformation Due to Compressive Stress; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE VALVE ALLEGEDLY WAS NOT SPLIT PROPERLY. THE UNIT WAS PLACED INTO THE PATIENT BUT A PORTION OF THE AREA WAS CUT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866209 ↗MalfunctionJun 9, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO CATHETER PLACEMENT, THERE WAS ALLEGEDLY ABOUT A FOUR INCH CUT INTO THE TOP DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11964213 ↗MalfunctionMay 25, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT DURING PREPARATION OF AN CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876674 ↗MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD BLOOD LEAK AFTER LAST BLOOD DRAW. IT WAS FURTHER REPORTED THAT THE LINE WAS LOCKED WITH HEPARIN SINCE HER BONE MARROW TRANSPLANT AND THE PATIENT RECEIVED PLATELETS DURING LAST ACCESS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10842169 ↗MalfunctionOct 18, 2019Defective Component; Defective Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0805915 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9209551 ↗MalfunctionJul 17, 2019Suction Problem; Suction Problem
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0805915 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A SUCTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE FEMALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8800638 ↗MalfunctionFeb 16, 2018Crack; Difficult to Remove
THE FACILITY HAS BEEN USING THE POWER HICKMAN FOR APPROX. 3 MONTHS AND HAVE SEEN 4 CASES OF DIFFICULTY REMOVING THE MAX ZERO CAP WITH AT LEAST ONE CASE OF HUB CRACK. THEY CONFIRMED THEY USE ALCOHOL WITH 15 SEC SCRUB AND 15 SEC DRY BEFORE ATTACHING THE MAX ZERO CAP. THE PATIENT POPULATION ARE PEDI CANCER PATIENTS. THEY HAVE BEEN ABLE TO REPAIR BEFORE PULLING THE LINES. THIS FILE IS BEING OPENED FOR THE PLACEMENT DATE OF (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278784 ↗
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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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