Hickman 0600620Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741051913), received between Apr 13, 2017 and Mar 26, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Packaging Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, IT WAS IDENTIFIED THAT THE PACKAGING OF CERTAIN CATHETER KITS MAY SUSTAIN DAMAGE TO THE OUTER TRAY, WHICH COULD POTENTIALLY COMPROMISE THE STERILE BARRIER. THE PRODUCT UTILIZES A DOUBLE-TRAY PACKAGING CONFIGURATION (OUTER AND INNER TRAYS). AS A RESULT, THE STERILITY OF THE OUTER SURFACE OF THE INNER TRAY AND THE INSTRUCTIONS FOR USE (IFU) MAY BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697139 ↗
• MalfunctionMar 26, 2026Packaging Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, IT WAS IDENTIFIED THAT THE PACKAGING OF CERTAIN CATHETER KITS MAY SUSTAIN DAMAGE TO THE OUTER TRAY, WHICH COULD POTENTIALLY COMPROMISE THE STERILE BARRIER. THE PRODUCT UTILIZES A DOUBLE-TRAY PACKAGING CONFIGURATION (OUTER AND INNER TRAYS). AS A RESULT, THE STERILITY OF THE OUTER SURFACE OF THE INNER TRAY AND THE INSTRUCTIONS FOR USE (IFU) MAY BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697136 ↗
• InjuryAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT HICKMAN D/L CATHETERS PLACEMENT PROCEDURE. ON (B)(6), IT WAS REPORTED THAT THE POST PLACEMENT PROCEDURE, SUBCUTANEOUS LEAKAGE WAS CONFIRMED. ADDITIONALLY, REDNESS WAS NOTED AROUND THE NECK. IT WAS REPLACED AND THE ACTUAL PRODUCT WAS CHECKED WITH A FLASH, BUT NO HOLES OR OTHER DEFECTS WERE FOUND. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 22881871 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A SPLIT RIGHT NEAR THE WHITE ADAPTOR LEG CUFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556888 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY A SPLIT RIGHT NEAR THE WHITE ADAPTOR LEG CUFF. IT WAS FURTHER REPORTED THAT THE RUBBER FELT MUCH SOFTER. FURTHERMORE, THE FLUID HAD ALLEGEDLY LEAKED OUT OF THE SITE WHERE THERE WAS A SPLIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521387 ↗
• MalfunctionJan 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE HAIR WAS ALLEGEDLY WRAPPED AROUND THE CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167008 ↗
• MalfunctionDec 9, 2024Fracture; Material Separation; Stretched; Material Integrity Problem; Fracture; Material Separation; Stretched; Material Integrity Problem

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT IN THE CERVICAL REGION AND RIGHT HEMITHORAX, THE GUIDEWIRE WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875846 ↗
• InjuryOct 22, 2024Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture; Suction Problem; Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture; Suction Problem

  IT WAS REPORTED THAT TEN MONTHS AND TEN DAYS POST A PORT PLACEMENT, WHEN FLUSHED THE LUMEN IT WAS NOTICED THAT SALINE WAS LEAKING OUT AT AN OBVIOUS SPLIT IN THE LUMEN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BLOOD CULTURES (ACINETOBACTER NOSOCOMIALIS) AND EXPOSED TO EXTERNAL CONTAMINATION. REPORTEDLY, PATIENT HAD SYMPTOMS OF SEPSIS INCLUDING FEVER AND RIGORS. BLOOD CULTURES FROM THE HICKMAN SHOWED GRAM POSITIVE COCCI AND ANTIBIOTICS WERE GIVEN. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 20503247 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH BACTEREMIA. IT WAS FURTHER REPORTED THAT THE INFECTED CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATENT IS UNKNOWN.

  Patient problems: Bacteremia

  MAUDE report 19508389 ↗
• MalfunctionNov 30, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO MONTHS POST A CHRONIC CATHETER PALCEMENT, A LEAKAGE WAS ALLEGEDLY FOUND JUST BELOW THE BIFURCATION OF THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238842 ↗
• MalfunctionNov 28, 2023Fracture; Material Separation; Stretched; Unraveled Material; Fracture; Material Separation; Stretched; Unraveled Material

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY SNAPPED INTO FIBER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18214633 ↗
• MalfunctionApr 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE SERUM ALLEGEDLY LEAKED THROUGH WHITE PATHWAY OF 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 16706457 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE CATHETER ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130253 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SEVEN MONTHS AND TWO DAYS CHRONIC CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE RED LUMEN OF THE DEVICE WAS ALLEGEDLY LEAKED. THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13629138 ↗
• MalfunctionMar 1, 2022Burst Container or Vessel; Fluid/Blood Leak; Fracture; Obstruction of Flow; Burst Container or Vessel; Fluid/Blood Leak; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT SEVEN MONTHS AND FOUR DAYS POST CHRONIC CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT LUMEN ALLEGEDLY BLOCKED DURING FLUSHING. THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13629129 ↗
• InjurySep 8, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED HEMATOMA AND LOCAL INFILTRATION. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hematoma; Infiltration into Tissue

  MAUDE report 12437403 ↗
• MalfunctionAug 15, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, DEVICE ALLEGEDLY HAD A FLUID LEAK. IT WAS FURTHER REPORTED THAT, THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322341 ↗
• MalfunctionAug 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272448 ↗
• MalfunctionMar 10, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD AN HOLE ON PLASTIC HUB WHICH IS NEXT TO WHITE LUMEN. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED AND PLACED ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452408 ↗
• MalfunctionMar 10, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED DURING A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A HOLE IN THE WHITE LUMEN NEXT TO THE PLASTIC HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452398 ↗
• MalfunctionJan 11, 2021Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE CUFF IS CAME OFF FROM 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 11145365 ↗
• MalfunctionDec 1, 2020Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY SPLIT WHILE FLUSHING WITH 10ML NORMAL SALINE. IT WAS FURTHER REPORTED THAT THE SPLIT WAS LOCATED APPROX 1CM EXTERNALLY FROM THE EXIT SITE AND FLUID LEAKING OUT UNDERNEATH DRESSING. REPORTEDLY THE HICKMAN CEASED, AND PATIENT CANNULATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926584 ↗
• MalfunctionOct 20, 2020Burst Container or Vessel; Obstruction of Flow; Material Split, Cut or Torn; Burst Container or Vessel; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS REMOVED DUE TO A SPLIT AT THE END OF THE LUMEN. THERE WAS REPORTED PATIENT INJURY.

  Patient problems: Fever; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10703588 ↗
• MalfunctionJul 16, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0600620 CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS ALLEGEDLY EXPERIENCED FRACTURE. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO MALFUNCTIONS, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR BOTH PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286144 ↗
• MalfunctionApr 10, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600620 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FAILURE TO BOND. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950864 ↗