Hickman 0606560Recalls & reported problems
Bard Access Systems, Inc. · Hickman 10F Triple-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Cuff · Class 2 · Implant
All models of Hickman (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Hickman central venous catheter is a long-term implanted vascular access device. The 81 reports mostly describe catheter fractures, leaks, and breaks; there are no deaths and 8 injuries. One recall is open, started December 2025, because outer tray damage may compromise the sterile barrier. Reports rose to 24 in the last 12 months, from 8 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00801741052019), received between Aug 31, 2017 and Jul 8, 2026 — classified as 7 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Fracture” (32 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Dec 12, 2025Open, Classified
Due to damage to outer tray that can potentially compromise the sterile barrier
Z-1367-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture32
- Fluid/Blood Leak27
- Burst Container or Vessel13
- Air/Gas in Device11
- Material Puncture/Hole8
- Break6
- Material Deformation5
- Restricted Flow rate4
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient23
- No Known Impact Or Consequence To Patient10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bacteremia2
- Bacterial Infection2
- High Pulmonary Arterial Wedge Pressure2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Fluid/Blood Leak; Fracture
On (b)(6) 2026, a patient underwent a chronic catheter placement procedure using a Hickman/Leonard/Broviac Central Venous Catheter. On (b)(6) 2026, following the procedure, a small tear was observed in the blue lumen during flushing, along with a minor trickle of blood from the affected site. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749506 ↗MalfunctionMay 13, 2026Fracture
THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157850 ↗MalfunctionMay 13, 2026Fracture
THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157841 ↗MalfunctionApr 30, 2026Fluid/Blood Leak; Fracture; Material Split, Cut or Torn
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2026, THE PORT SPLIT AND STARTED LEAKING WHEN THE NURSE FLUSHED THE LINE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038977 ↗MalfunctionApr 30, 2026Fluid/Blood Leak; Fracture; Material Split, Cut or Torn
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2026, THE PORT SPLIT AND STARTED LEAKING WHEN THE NURSE FLUSHED THE LINE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038972 ↗MalfunctionApr 21, 2026Burst Container or Vessel; Fracture; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, THE IMPLANTED CATHETER WAS REPORTED TO BE RUPTURED. THE AFFECTED CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER DEVICE ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939494 ↗MalfunctionApr 21, 2026Burst Container or Vessel; Fracture; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. POST THE PROCEDURE ON (B)(6) 2026, THE NURSING STAFF OBSERVED A RUPTURE IN THE LUMEN OF THE REPLACEMENT CATHETER. REPORTEDLY, THE CHEMOTHERAPY TREATMENT HAD NOT YET BEEN COMPLETED, THE CATHETER WAS TEMPORARILY COVERED UNTIL THE THERAPY CONCLUDED. AS PER THE RECOMMENDATION OF INTERVENTIONAL RADIOLOGY, THE CATHETER WAS REMOVED ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939493 ↗MalfunctionMar 24, 2026Material Puncture/Hole
A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUSTOMER OBSERVED THE PRESENCE OF A HOLE IN THE CENTRAL VENOUS CATHETER (CVC). THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679945 ↗MalfunctionFeb 19, 2026Stretched; Material Protrusion/Extrusion; Air/Gas in Device
ON (B)(6) 2025, A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE DEVICE SHOWED A BUBBLE. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386180 ↗MalfunctionFeb 19, 2026Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385266 ↗MalfunctionFeb 18, 2026Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385172 ↗MalfunctionFeb 18, 2026Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385171 ↗MalfunctionFeb 18, 2026Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385168 ↗MalfunctionFeb 18, 2026Fracture; Air/Gas in Device
ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WHILE BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER WAS FOUND TO BE RUPTURED AND RESULTED IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS AND REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385121 ↗MalfunctionFeb 18, 2026Fracture; Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385120 ↗MalfunctionFeb 18, 2026Fracture; Air/Gas in Device
ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WHILE BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER WAS FOUND TO BE RUPTURED AND RESULTED IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS AND REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385118 ↗MalfunctionFeb 18, 2026Fracture; Air/Gas in Device
ON (B)(6) 2025, IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385116 ↗MalfunctionJan 8, 2026Fracture
A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. POST THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN AND ISOLATED. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR AN EMERGENCY CATHETER REPLACEMENT. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24000704 ↗MalfunctionJan 6, 2026Air/Gas in Device
A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE BY USING HICKMAN CATHETER. ON (B)(6) 2025, IT WAS REPORTED THAT DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23972236 ↗MalfunctionJan 6, 2026Fracture; Air/Gas in Device
A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE BY USING HICKMAN CATHETER. ON (B)(6) 2025, IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23972038 ↗MalfunctionNov 19, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
ON (B)(6) 2024, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. ONE YEARS 9 MONTHS AND 5 DAYS POST PROCEDURE, THE LINE ALLEGEDLY HAD A LEAK. LINE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia; Bacterial Infection; High Pulmonary Arterial Wedge Pressure; No Clinical Signs, Symptoms or Conditions
MAUDE report 23590802 ↗InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (b)(6) 2024, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. ONE YEAR NINE MONTHS AND FOUR DAYS POST PROCEDURE THE PATIENT ALLEGEDLY REPORTED PULMONARY HYPERTENSION CNS AND ALSO TREATED FOR A STAPH AUREUS BACTEREMIA AND REMAINS AN INPATIENT. IV FLUCLOAXACILLIN AND IV GENTAMICIN GIVEN FOR THE INFECTION. LINE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia; Bacterial Infection; High Pulmonary Arterial Wedge Pressure
MAUDE report 23590795 ↗MalfunctionNov 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN. IT WAS REPORTED THAT POST PROCEDURE, THE HICKMAN LINE WAS ALLEGEDLY HAD A HOLE IN THE WHITE LUMEN AND LEAK WAS FOUND IN THE WHITE LUMEN IMMEDIATELY DISTAL TO THE TRIFURCATIONS. THE CATHETER HAS BEEN REMOVED AND A PICC PLACED TO FURTHER FACILITATE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23447825 ↗MalfunctionSep 15, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN. IT WAS REPORTED THAT POST PROCEDURE, ON (B)(6) 2025, THE HICKMAN LINE WAS ALLEGEDLY HAD A HOLE IN THE WHITE LUMEN. THE CATHETER HAS BEEN REMOVED AND A PICC PLACED TO FURTHER FACILITATE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23048675 ↗MalfunctionAug 8, 2025Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Puncture/Hole
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIPLE LUMEN CATHETER. ON (B)(6) 2025, ONE MONTH AND FIVE DAYS LATER POST CHRONIC CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY LEAKING WITH BLOOD FOLLOWING FLUSHING. IT WAS FURTHER REPORTED THAT THE LINE WAS ALLEGEDLY FOUND BURST. ON (B)(6) 2025, THE DEVICE WAS REMOVED. REINSERTION OF TUNNELED CVC TO COMPLETE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Erythema; Extravasation; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema
MAUDE report 22749958 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page