Hickman 0601680Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741036415), received between Feb 24, 2017 and Jan 29, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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. Jan 4, 2023Open, Classified

   Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

   Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Loose or Intermittent Connection

  ON (B)(6) 2026, A BROVIAC CATHETER WAS REPAIRED USING THE HICKMAN/LEONARD/BROVIAC REPAIR KIT. IT WAS REPORTED THAT DURING THE REPAIR, IT WAS NOTED THAT THE SMALL METAL PIECE, WHICH ALLEGEDLY CONNECTS THE REPAIR TO THE LINE, WAS NOT STABLE OR PROPERLY GLUED IN PLACE. THE COMPONENT WAS MOVABLE, RAISING CONCERN FROM THE ATTENDING NURSE THAT IT COULD POTENTIALLY FLUSH OFF INTO THE LINE OR PATIENT IF THE LINE WERE FLUSHED WITH EXCESSIVE FORCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207258 ↗
• MalfunctionNov 6, 2025Burst Container or Vessel; Material Puncture/Hole; Device Dislodged or Dislocated; Burst Container or Vessel; Material Puncture/Hole; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A REPAIR KIT PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC REPAIR KIT. ON (B)(6) 2025, POST THE PROCEDURE IT WAS NOTED THAT THE METAL PIN MOVED OUT OF SLICE AREA. THE INTERNAL METAL PIN HAS TRAVELED DOWN THE LINE AND CREATED A HOLE OUTSIDE THE SLEEVE IN THE REPAIR ZONE. LINE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484226 ↗
• MalfunctionOct 9, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THE WHITE LUMEN EXTENSION SET WAS ALLEGEDLY FOUND CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23252427 ↗
• MalfunctionOct 7, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PROCEDURE USING HICKMAN CATHETER. POST PROCEDURE, THE WHITE LUMEN REPAIRED SEGMENT HAD A LARGE CRACK. THERE WAS NO REPORTED PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23231041 ↗
• MalfunctionJan 18, 2023Moisture Damage; Device Contaminated During Manufacture or Shipping; Moisture Damage; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PACKAGING ALLEGEDLY HAD MOISTURE DAMAGE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY CONTAMINATED WITH DIRT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191616 ↗
• MalfunctionAug 5, 2022Fluid/Blood Leak; Material Puncture/Hole; Stretched; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Puncture/Hole; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST CATHETER REPAIR PLACEMENT, THE CATHETER ALLEGEDLY HAD HOLE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY GOT BALLOONED WHILE FLUSHING AND THE CATHETER ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173337 ↗
• MalfunctionJun 14, 2022Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A CATHETER REPAIR PROCEDURE, THE BALLOONING WAS ALLEGEDLY NOTED ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683028 ↗
• MalfunctionApr 8, 2022Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A CATHETER REPAIR PROCEDURE, THE DEVICE WAS ALLEGEDLY HERNIATED WHEN THEY WENT TO USE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14050332 ↗
• MalfunctionJan 10, 2020Stretched; Material Deformation; Stretched; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601680 PORT AND CATHETER ACCESSORY ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE AND WEIGHT OF THE MALE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576326 ↗
• MalfunctionJul 17, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGING OF A MODEL 0601680 CENTRAL VENOUS CATHETER. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8801018 ↗
• MalfunctionMay 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FACILITY HAS ALLEGED THE CATHETER HAS HOLES IN THE TUBING, SMALL SPLITS IN THE TUBING AND/OR SEPARATION AT THE REPAIR KIT. DEVICE WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535507 ↗
• MalfunctionFeb 24, 2017Hole In Material

  AS REPORTED BY THE FACILITY, A PINHOLE WAS NOTED AT THE HUB OF THE WHITE LUMEN BUT WAS NOT ALL THE WAY THROUGH THE CATHETER. INNER CANNULA SEPARATION WAS NOTED ON THE WHITE LINE WITH BLOOD IN BETWEEN THE LAYERS. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6356936 ↗