Broviac 0601610Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741036385), received between Apr 8, 2016 and Jun 4, 2026 — classified as 6 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Discolored; Air/Gas in Device

  A PATIENT UNDERWENT CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. AFTER SOME TIME, IT WAS NOTED THAT THE EXTERNAL PORTION OF THE CATHETER TUBING HAD TURNED PINK, AND AN AIR BUBBLE WAS OBSERVED WITHIN IT IN THE EXTERNAL PORTION THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391246 ↗
• MalfunctionDec 1, 2025Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  A PATIENT UNDERWENT A REPAIR KIT PLACEMENT PROCEDURE USING THE HICKMAN REPAIR KIT. ON (B)(6) 2025, THE CRACK WAS NOTED ON REPAIR LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678597 ↗
• MalfunctionAug 14, 2024Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN POSITIVE PRESSURE WAS APPLIED, A PART OF THE CATHETER WAS ALLEGEDLY FOUND TO BE EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981655 ↗
• MalfunctionAug 6, 2024Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE METAL STENT IN THE REPAIR KIT ALLEGEDLY MIGRATED. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917600 ↗
• MalfunctionJan 31, 2024Loss of or Failure to Bond; Material Separation; Device Dislodged or Dislocated; Loss of or Failure to Bond; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER REPAIR PROCEDURE, THE METAL PIECE ALLEGEDLY DID NOT STAY UNDER THE SLEEVE AFTER THE REPAIR. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED AN ADDITIONAL REPAIR OF THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611951 ↗
• MalfunctionDec 13, 2023Fracture; Fracture

  IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE ¿JAPANESE SOCIETY OF PEDIATRIC SURGEONS¿ TITLED "COMPLICATIONS AND MANAGEMENT OF CENTRAL VENOUS CATHETERS OF LONG-TERM TOTAL PARENTAL NUTRITION", THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE EXTERNAL PART OF THE CATHETER WAS ALLEGEDLY BROKEN. REPORTEDLY, THE BROKEN CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316669 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE ¿JAPANESE SOCIETY OF PEDIATRIC SURGEONS¿ TITLED "COMPLICATIONS AND MANAGEMENT OF CENTRAL VENOUS CATHETERS OF LONG-TERM TOTAL PARENTAL NUTRITION", THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED A CATHETER TUNNEL INFECTION DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia

  MAUDE report 18310280 ↗
• MalfunctionDec 12, 2023Fracture; Fracture

  IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE ¿JAPANESE SOCIETY OF PEDIATRIC SURGEONS¿ TITLED "COMPLICATIONS AND MANAGEMENT OF CENTRAL VENOUS CATHETERS OF LONG-TERM TOTAL PARENTAL NUTRITION", THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE EXTERNAL PART OF THE CATHETER WAS ALLEGEDLY BROKEN. REPORTEDLY, THE BROKEN CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310140 ↗
• MalfunctionSep 14, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE GLUE WAS ALLEGEDLY DRIED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743363 ↗
• MalfunctionSep 8, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO A REPAIR KIT PLACEMENT PROCEDURE, GLUE WAS ALLEGEDLY DRIED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709471 ↗
• MalfunctionJul 5, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259358 ↗
• MalfunctionJun 5, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE HAD THE INTACT FOIL SEAL OVER THE END. IT WAS FURTHER REPORTED THAT THE GLUE WAS ROCK HARD WHEN PUNCTURED THE SEAL WITH THE CAP. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058604 ↗
• MalfunctionApr 6, 2023Fracture; Stretched; Material Protrusion/Extrusion; Fracture; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY STARTED OUT AS AN ANUERYSM AND EVENTUALLY TORN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689904 ↗
• MalfunctionMar 27, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617193 ↗
• MalfunctionMar 27, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617142 ↗
• MalfunctionFeb 16, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIRING PROCEDURE, THE ADHESIVE ON THE DEVICE WAS ALLEGEDLY SOLID AND WOULDN'T COME OUT OF TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385692 ↗
• MalfunctionFeb 8, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARDENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324166 ↗
• MalfunctionFeb 7, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARDENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316288 ↗
• MalfunctionJan 31, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION OF A CATHETER REPAIR PROCEDURE, THE GLUE WAS ALLEGEDLY HARDENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270156 ↗
• MalfunctionJan 12, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT APPROXIMATELY FOURTEEN DAYS POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DETACHED FROM THE PART OF THE ADHESIVE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143673 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193974 ↗
• MalfunctionApr 21, 2022Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT TWENTY TWO DAYS POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BULGED WITH FLUSHING. THE PROCEDURE WAS COMPLETED BY PLACING REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165818 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN. THERE WAS REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12734525 ↗
• MalfunctionAug 31, 2021Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST CATHETER PLACEMENT, THE REPAIR KIT ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390220 ↗
• MalfunctionJun 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT, THE TWO REPAIR SHEATHS ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006262 ↗