Hickman 0600570Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00801741051869), received between Dec 17, 2015 and Sep 18, 2026 — classified as 1 death, 24 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Fracture” (79 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 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fracture; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823212 ↗
• MalfunctionSep 18, 2026Packaging Problem

  It was reported that the Hickman CV Catheter lot had been subject to a recall approximately two months earlier due to a packaging issue. There was no reported patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814855 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak; Fracture

  A 4 year old female patient underwent a catheter placement procedure using the Hickman CV Catheter. It was reported that on May 3, 2026, approximately 459 days post implantation procedure, patient was found to have a rupture located above the catheter hub on the large (red) lumen. The issue was identified while the patient was at home, and no IV medication had been administered during the preceding two weeks. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798763 ↗
• MalfunctionSep 17, 2026Disconnection; Fluid/Blood Leak

  A 19 month old male patient underwent a catheter placement procedure using the Hickman CV Catheter. On (b)(6) 2026, approximately 16 days post implantation procedure, the patient experienced immediate leakage from the small lumen during flushing. Leakage was observed within the first 3 mL of a 10 mL saline flush. The reporter also noted that a line disconnection had been identified two days prior to the event. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798757 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak; Fracture

  A 2 year old female patient underwent a catheter placement procedure using the Hickman CV Catheter. On (b)(6) 2026, approximately 125 days post implantation a catheter rupture was found at the hub site. The event was initially identified at home when blood was observed on the patients clothing and was subsequently confirmed in the emergency department after the clamp was reopened. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798756 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole

  On (b)(6) 2026, A patient underwent a chronic catheter placement procedure using the Hickman CV Catheter. It was reported that during the procedure, a leak was detected from the catheter, and upon removing it, a pinhole was discovered. Additionally, catheter break was noted. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50709938 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  On (b)(6) 2026, a patient underwent a central venous catheter placement procedure using Hickman/Leonard/Broviac Central Venous Catheter. On (b)(6) 2026, while changing the catheter cap, the nurse observed blood coming from the catheter tubing located above the red lumen and below the bifurcation of the double lumen tunneled central venous catheter. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50686893 ↗
• MalfunctionAug 31, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523200 ↗
• MalfunctionAug 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517931 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak; Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress

  On (b)(6) 2026, a patient underwent a catheter placement procedure using a Hickman/Leonard/Broviac Central Venous Catheter. After a period of use, on (b)(6) 2026, inadequate securement and line management, along with continuous stretching, twisting, and kinking of the line, resulted in an almost complete tear/rupture of the white lumen of the dual lumen tunneled line. It was further reported that the issue was identified when blood leakage was observed on the bed. The catheter was subsequently repaired using a repair kit. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50468916 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138993 ↗
• MalfunctionJun 5, 2026Burst Container or Vessel; Material Protrusion/Extrusion

  ON (B)(6) 2026, THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. AFTER SOME TIME, WHILE FLUSHING THE CATHETER, IT WAS REPORTED THAT ONE OF THE LUMENS OF THE CATHETER HAD BURST AT THE BIFURCATION. THE CATHETER WAS REPAIRED, AND ANTIBIOTICS WERE INFUSED THROUGH THE OTHER LUMEN. HOWEVER, DURING INFUSION, THE OTHER LUMEN BEGAN TO BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404075 ↗
• MalfunctionMay 5, 2026Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE CENTRAL VENOUS CATHETER. DURING THE PROCEDURE ONE OF THE LUMENS WAS REPORTEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25077257 ↗
• InjuryMar 23, 2026Fluid/Blood Leak; Fracture; Material Separation

  ON (B)(6) 2025, A 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 RED LUMEN OF THE DOUBLE-LUMEN CATHETER HAD COMPLETELY BROKEN AT THE BASE OF THE BIFURCATION DURING CONTINUOUS INFUSION. IT WAS FURTHER REPORTED THAT THERE WAS LEAKAGE ON THE SURFACE OF THE BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 24659627 ↗
• MalfunctionMar 9, 2026Fracture; Material Puncture/Hole

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING INDWELLING DUAL LUMEN HICKMAN CATHETER. 10 DAYS POST PROCEDURE, THE CATHETER REQUIRED REMOVAL AFTER A SMALL PINHOLE WAS DISCOVERED IN THE CATHETER. THE LINE WAS REMOVED ON THE SAME DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543461 ↗
• MalfunctionDec 24, 2025Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. DURING THE PROCEDURE THE CATHETER WAS OBSTRUCTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886916 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, CATHETER WAS ALLEGEDLY FOUND LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862114 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING A HICKMAN CV CATHETER. APPROXIMATELY FOUR MONTHS AFTER THE PROCEDURE, THE LUMENS AT THE CATHETER¿S CUFF JUNCTION WERE FOUND TO BE FRACTURED AND LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813630 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, DUAL-LUMEN, 7F. POST THE PROCEDURE, IT WAS FOUND THAT THE RED LUMEN OF THE LINE ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813145 ↗
• InjuryDec 4, 2025Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. 9 MONTHS AND 17 DAYS POST PROCEDURE, THE PATIENT GOT CAUGHT VERY SLIGHTLY ON THE INFUSION CABLE AND THE HICKMAN CATHETER WAS TORN DISTALLY AT THE V-CUFF, CAUSING BLOOD TO FLOW OUT OF THE TORN CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS BLEEDING FROM THE CATHETER, WHICH FORTUNATELY COULD BE STOPPED BY CLAMPING. THE CATHETER HAD TO BE SURGICALLY REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23713607 ↗
• InjuryNov 18, 2025Difficult to Flush; Fracture; Material Separation; Suction Problem; Air/Gas in Device; Difficult to Flush; Fracture; Material Separation; Suction Problem; Air/Gas in Device

  ON (B)(6) 2024, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. 1 YEARS 3 MONTHS AND 18 DAYS POST PROCEDURE THE CATHETER ALLEGEDLY FOUND BROKEN AND RED LUMEN OF THE CATHETER DETACHED FROM THE WHITE PLASTIC BASE. IT WAS ALSO NOTICED A FEW BUBBLES IN THE ARTERIAL LINE OF THE DIALYSIS CIRCUIT. NO AIR BUBBLES PASSED INTO THE VENOUS LINE OF THE DIALYSIS CIRCUIT. DUE TO THE PRESENCE OF AIR NEAR THE CLAMP OF THE RED LUMEN OF THE CATHETER, NO REINFUSION WAS PERFORMED. AS A RESULT, A TOTAL OF 105 ML OF BLOOD WAS LOST. THE CATHETER WAS NOT FLUSHED OR CITRATE LOCKED. THE PATIENT WAS SENT URGENTLY TO IR FOR CATHETER REPLACEMENT. NO ISSUES NOTED FROM THE RED LUMEN. LUMEN RE-KITE LOCKED AND BLOCKED OFF FROM FURTHER USE UNTIL GEN-SURG TO COME DO A REPAIR. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23579734 ↗
• MalfunctionOct 31, 2025Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. DURING THE PROCEDURE, THE CUFF ALLEGEDLY DETACHED, RESULTING IN EXTENDED PROCEDURE TIME FOR REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434232 ↗
• MalfunctionOct 6, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  A PATIENT UNDERWENT A PLACEMENT OF HICKMAN CATHETER PLACEMENT PROCEDURE FOR AN UNKNOWN MEDICAL CONDITION. ON (B)(6) 2025, A BULGING WAS OBSERVED IN THE WHITE LUMEN OF THE DEVICE DURING FLUSHING. THE DEVICE HAD BEEN INSERTED ON (B)(6) 2025, AND SUBSEQUENTLY REMOVED ON (B)(6) 2025. THE INCIDENT WAS REPORTED FOLLOWING THE REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23219525 ↗
• MalfunctionOct 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT UNDERWENT A PLACEMENT OF HICKMAN CATHETER FOR AN UNKNOWN MEDICAL CONDITION. ON (B)(6) 2025, A LEAK WAS IDENTIFIED AT THE DISTAL END OF THE WHITE LUMEN OF THE DEVICE. THE AFFECTED DEVICE HAD BEEN REMOVED FROM THE PATIENT ON (B)(6) 2025. THE ISSUE WAS REPORTED ON THE SAME DAY IT WAS DISCOVERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23219473 ↗
• MalfunctionOct 6, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A HICKMAN CATHETER PLACEMENT PROCEDURE FOR AN UNKNOWN MEDICAL CONDITION. ON (B)(6) 2025, A LEAK WAS IDENTIFIED IN A HICKMAN LINE, WHICH WAS ALSO REPORTED TO BE BROKEN WITHIN THE CATHETER. THE DEVICE HAD BEEN INSERTED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2025. THE INCIDENT WAS REPORTED PRIOR TO REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23219472 ↗