Hickman 0600560Recalls & reported problems
Bard Access Systems, Inc. · Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Bard Hickman catheter is a long-term tube placed in a large vein for ongoing treatment. Its 52 reports mostly describe cracking, holes and leaking, sometimes with clogging, and mention no deaths and 5 injuries. It has 1 open recall started in December 2025 about damage to the outer tray that could affect sterility.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741051845), received between Mar 11, 2016 and Sep 9, 2026 — classified as 5 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Fracture19
- Fluid/Blood Leak10
- Adverse Event Without Identified Device or Use Problem7
- Material Puncture/Hole6
- Break5
- Obstruction of Flow5
- Material Separation4
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient6
- Rash2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- No Information1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Fracture; Improper or Incorrect Procedure or Method
On (b)(6) 2026, the patient underwent a central venous catheter placement procedure using a Hickman CV Catheter. After some time, on (b)(6) 2026, it was noted that a crack had developed in the plastic hub due to improper clamping too close to the hub. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690889 ↗MalfunctionApr 30, 2026Material Puncture/Hole
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, UPON OPENING THE PACKAGE, IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038735 ↗MalfunctionFeb 16, 2026Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture; Obstruction of Flow; Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2025, POST PLACEMENT PROCEDURE, A CRACK ALLEGEDLY DEVELOPED. DURING FLUSHING AFTER ADMINISTRATION, THE LINE REPORTEDLY BECAME CLOGGED, AND FLUSH FLUID WAS OBSERVED BUBBLING AND SUBSEQUENTLY SQUIRTING OUT OF THE CATHETER. THE ISSUE WAS RESOLVED FOLLOWING REPAIR OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342739 ↗MalfunctionNov 17, 2025Fracture; Nonstandard Device; Material Puncture/Hole; Fracture; Nonstandard Device; Material Puncture/Hole
ON (B)(6) 2025 A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE CATHETER WAS ALLEGEDLY HAD A HOLE NEAR THE HUB THAT WAS NOTED UPON OPENING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566004 ↗MalfunctionSep 15, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
ON (B)(6) 2025 A PATIENT UNDERWENT CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING A HICKMAN INSTRUMENT FOR UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE THE CATHETER WAS ALLEGEDLY FOUND LEAKING. THE PROCEDURE WAS DONE BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051716 ↗MalfunctionMar 27, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705638 ↗MalfunctionMar 7, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY SPLIT NEAR THE CUFF. IT WAS FURTHER REPORTED THAT THE INFUSION FLUID WAS LEAKING OUT OF THE CATHETER DURING INFUSION AND GOING ON HER SKIN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546428 ↗MalfunctionMar 7, 2025Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole
IT WAS REPORTED THAT APPROXIMATELY FOUR-FIVE YEARS POST A CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A PINHOLE NEAR THE HUB OF THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE LEAK WAS NOTED DURING INFUSE. THE PROCEDURE WAS COMPLETED BY EXCHANGING THE PINHOLE USING A REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546194 ↗MalfunctionMar 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE DOCUMENTED LENGTH IS FROM CUFF TO TIP OF LINE BUT NO INFORMATION NOTED ON REMAINDER OF LUMEN LENGTH. IT WAS FURTHER REPORTED THAT NO TOTAL CATHETER LENGTH ON PACKAGING EITHER WAS ALLEGEDLY MENTIONED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543521 ↗MalfunctionFeb 3, 2025Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY FOUND TO BE IN HALF. IT WAS FURTHER REPORTED THAT APPROXIMATELY THREE INCHES OF THE CATHETER HAD SPLIT OFF. REPORTEDLY, THE CLAMP WAS ALSO OFF AND THE EXPOSED LENGTH OF THE CATHETER LEFT ON PATIENT APPROXIMATELY FIVE INCHES. ADDITIONALLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291600 ↗MalfunctionJan 1, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT ONE YEAR, FOUR MONTHS, AND SIXTEEN DAYS POST A PORT PLACEMENT. THE CATHETER ALLEGEDLY HAD BLOCKAGE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21051120 ↗MalfunctionJul 1, 2024Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT ELEVEN MONTHS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE WHITE ADAPTOR END WAS ALLEGEDLY SEPARATED INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE TWO PIECES WERE GLUED TOGETHER BUT IT WAS UNSUCCESSFUL. REPORTEDLY, THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641626 ↗MalfunctionJun 14, 2024Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT THREE WEEKS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE CONNECTION OF THE CATHETER CAME LOOSE AND ALLEGEDLY BROKE OFF. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19535425 ↗MalfunctionFeb 2, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT NINE MONTHS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT UPON RADIOLOGICAL CHECK, THE INSPECTION ALLEGEDLY SHOWED EXTRAVASATION OF CONTRAST MEDIUM THROUGH CRACKS IN THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630041 ↗MalfunctionJan 3, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT ONE YEAR AND EIGHT DAYS POST A CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18433272 ↗InjuryJul 28, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CUFF ALLEGEDLY CAUSED INFECTION. IT WAS FURTHER REPORTED THAT ANTIBIOTICS WERE PRESCRIBED TO TREAT INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 17411509 ↗MalfunctionMay 27, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, WHEN THE CATHETER WAS ATTEMPTED TO BE INSERTED INTO THE SHEATH, THE CATHETER WAS ALLEGEDLY FOUND TO BE DAMAGED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND STOPPED INSERTING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17015400 ↗MalfunctionMar 2, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16465776 ↗MalfunctionMar 2, 2023Expulsion; Expulsion
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST CATHETER PLACEMENT PROCEDURE, CATHETER ALLEGEDLY MIGRATED OUTSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT CUFF ALLEGEDLY EXPOSED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16465741 ↗MalfunctionJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135592 ↗MalfunctionNov 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT SOME TIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY POWER INJECTED. IT WAS FURTHER REPORTED THAT THE IMPLANTED CATHETER IS A NOT A POWER INJECTABLE CATHETER. REPORTEDLY THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15812198 ↗MalfunctionOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15578501 ↗MalfunctionSep 20, 2022Fracture; Fracture
IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE DEVICE DISTAL END ALLEGEDLY FRACTURED WHEN FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15453256 ↗MalfunctionAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED SILICONE ALLERGY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15181070 ↗MalfunctionJul 30, 2022Fracture; Fracture
IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKEN AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136698 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.