Broviac 0600520Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 00801741051807), received between Mar 3, 2016 and Sep 21, 2026 — classified as 23 injuries, 242 malfunctions.

The most frequently reported specific device problem is “Fracture” (94 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 265 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fracture; Difficult to Remove; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  On (b)(6) 2026, a patient underwent a chronic catheter placement procedure using a Broviac CV Catheter. During the procedure, upon removal of the guidewire from its packaging, the tip was observed to be bent. The healthcare professional manually straightened the guidewire and proceeded with use. Following vascular puncture and guidewire insertion, the guidewire became stuck and subsequently fractured during removal. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837694 ↗
• MalfunctionSep 21, 2026Loose or Intermittent Connection

  A patient underwent a catheter placement procedure using a Broviac CV Catheter. On (b)(6) 2026, during use, the catheter clamp became loose and opened unintentionally. The issue reportedly occurred twice within one month. As a result, the clamp had to be secured with tape to continue using the catheter. The device remains within the patient. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837146 ↗
• MalfunctionSep 18, 2026Difficult to Flush; Fracture; Suction Problem

  A patient underwent a central venous catheter placement procedure using Broviac CV Catheter. On (b)(6) 2026, it was reported that the catheter fractured approximately two months after the device had been placed. It was also reported that the catheter could not be aspirated. As a result, the catheter was removed. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814278 ↗
• InjuryAug 26, 2026Fracture; Material Separation; Deformation Due to Compressive Stress; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  On (b)(6) 2026, a patient underwent placement of a Hickman/Leonard/Broviac Central Venous Catheter in the left internal jugular vein for the administration of chemotherapy to treat leukemia. Following the procedure, on (b)(6) 2026, it was discovered that the Broviac catheter had completely fractured. Prior to the fracture, the catheter had reportedly become twisted on multiple occasions due to patient movement in bed and had been subjected to tension while the patient was crawling; therefore, wear and tear associated with these factors was considered a possible contributing cause of the fracture. It was further reported that the catheter cuff was exposed outside the body, suggesting that it had become dislodged. The patient's current condition was unknown.

  Patient problems: Skin Erosion

  MAUDE report 50446950 ↗
• MalfunctionJun 5, 2026Material Protrusion/Extrusion

  ON (B)(6) 2026, A PATIENT UNDERWENT CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PORTION OF CATHETER WAS DAMAGED AND SUBSEQUENTLY REPAIRED USING A REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408168 ↗
• MalfunctionJun 3, 2026Material Discolored; Difficult to Flush; Suction Problem; Air/Gas in Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371035 ↗
• MalfunctionMay 18, 2026Material Discolored; Expulsion

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST IMPLANTATION, THE CATHETER WAS OBSERVED TO BE DISCOLORED PINK, WITH APPROXIMATELY 1 CM OF THE CATHETER EXTENDING BEYOND THE SKIN. FURTHER, SKIN EROSION AND EXPULSION WAS REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Erosion

  MAUDE report 25197551 ↗
• MalfunctionMay 15, 2026Material Discolored; Fracture

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE IMPLANTATION IT WAS NOTICED THE CLAMP AREA UP TO ABOUT ONE CM FROM THE INSERTION SITE, THE CATHETER HAS TURNED PINK AND WAS DUE TO AN INTERNAL RUPTURE IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25181962 ↗
• InjuryMar 23, 2026Obstruction of Flow; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. FOLLOWING IMPLANTATION, THE TISSUE CUFF WAS REPORTEDLY PROTRUDING OR HAD MIGRATED. IN ADDITION, THE CATHETER WAS OBSTRUCTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Erosion

  MAUDE report 24659467 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak; Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED CATHETER PLACEMENT PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. DURING MEDICATION ADMINISTRATION ON (B)(6) 2026, LEAKAGE OF HEPARIN SOLUTION WAS OBSERVED DUE TO DAMAGE AT THE TRANSITION FROM THE CLAMP AREA TO THE NARROW SEGMENT. ON THE PROXIMAL SIDE OF THE LARGE-DIAMETER TO SMALL-DIAMETER TRANSITION (APPROXIMATELY 30 MM), A V-SHAPED SPLIT WAS PRESENT, AND A PARTIAL (NON-COMPLETE) BREAK OF ABOUT 3 MM WAS OBSERVED AT THE BEND OF THE V-SHAPED SPLIT. REPORTEDLY, THE OUTER LAYER SHOWED A COMPLETE TEAR, WHILE A SMALL TEAR OF APPROXIMATELY 2 MM WAS IDENTIFIED IN THE INNER LAYER AT THE SAME SITE. FURTHERMORE, THE DAMAGED CATHETER WAS REPAIRED USING A REPAIR KIT. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453884 ↗
• MalfunctionFeb 25, 2026Burst Container or Vessel; Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING BROVIAC CV CATHETER, SINGLE LUMEN, 4.2F. IT WAS REPORTED THAT DURING BLOOD COLLECTION, THE CATHETER BROKE OPEN DISTALLY. A SMALL AMOUNT OF BLOOD WAS OBSERVED, AND THE BROVIAC LINE WAS IMMEDIATELY CLAMPED PROXIMAL TO THE PATIENT USING THREE CLAMPS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439763 ↗
• MalfunctionFeb 16, 2026Burst Container or Vessel; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING A PROCEDURE, THE CATHETER BECAME UNUSABLE DUE TO EXPANSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343766 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A BROVIAC CV CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ALLEGED LEAK FROM THE CONNECTOR DURING THE ADMINISTRATION OF MEDICATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277663 ↗
• MalfunctionFeb 4, 2026Burst Container or Vessel; Fluid/Blood Leak; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2026, POST-PROCEDURE, CRACKS AND FLUID LEAKAGE WERE OBSERVED NEAR THE BASE OF THE CATHETER. THE PRODUCT WAS REPAIRED USING A REPAIR KIT ON THE SAME DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255626 ↗
• MalfunctionJan 16, 2026Fracture; Material Separation; Suction Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT USING BROVIAC CV CATHETER, SINGLE LUMEN, 4.2F. IT WAS REPORTED THAT FOLLOWING AN ETHANOL LOCK PROCEDURE, THE SYRINGE COULD NOT BE ASPIRATED. WHEN SALINE WAS SUBSEQUENTLY INFUSED, THE EXTERNAL CATHETER RUPTURED AND BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091745 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fracture; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Fluid/Blood Leak; Fracture; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CATHETER. ON (B)(6) 2025, POST THE PROCEDURE THE LINE GETS TWISTED IN A CERTAIN SPOT REPEATEDLY RESULTING IN A CRACKED LINE. IT WAS ALSO NOTED THAT SALINE WAS COMING FROM A CRACK IN THE LINE JUST ABOVE THE REINFORCED CLAMPING AREA. A PORTION OF THE ORIGINAL LINE STILL REMAINED IN THE PATIENT, BUT IT WAS NOT A PART THAT BROKE THIS TIME. PATIENT BROUGHT INTO THE ED TO REPAIR THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678474 ↗
• MalfunctionOct 30, 2025Burst Container or Vessel; Material Discolored; Stretched; Material Protrusion/Extrusion; Burst Container or Vessel; Material Discolored; Stretched; Material Protrusion/Extrusion

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. DURING THE CATHETER REPLACEMENT PROCEDURE, IT WAS ALLEGEDLY THE AREA FROM THE THICK END OF THE CATHETER TO THE NARROWING STEP AND INSERTION POINT WAS FOUND TO BE DARK RED IN PATCHES. A BULGE WAS NOTED WITHIN THE CATHETER DIRECTLY BELOW THE STEP. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423423 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Air/Gas in Device; Fluid/Blood Leak; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. DURING THE PROCEDURE, THE OUTER LAYER OF THE LARGER CALIBER SECTION NEAR THE CLAMP WAS ALLEGEDLY FOUND BUBBLE FORMATION. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308208 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Air/Gas in Device; Fluid/Blood Leak; Fracture; Material Separation; Stretched; Material Protrusion/Extrusion; Air/Gas in Device

  IT WAS REPORTED THAT DURING A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE, THE OUTER LAYER OF THE LARGER CALIBER SECTION NEAR THE CLAMP ALLEGEDLY FOUND WITH BUBBLE FORMATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308148 ↗
• MalfunctionSep 16, 2025Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2025 A PATIENT UNDER A CHRONIC CATHETER PLACEMENT PROCEDURE FOR AN UNKNOWN MEDICAL CONDITION USING BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. DURING THE PROCEDURE THE CATHETER WAS FRACTURED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060658 ↗
• MalfunctionSep 11, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. SOMETIMES POST PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023580 ↗
• MalfunctionSep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE HICKMAN CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE WHEN AN ETHANOL LOCK WAS APPLIED, REDNESS APPEARED ALONG THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 22931800 ↗
• InjuryAug 6, 2025Burst Container or Vessel; Fluid/Blood Leak; Stretched; Material Protrusion/Extrusion; Burst Container or Vessel; Fluid/Blood Leak; Stretched; Material Protrusion/Extrusion

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN SINGLE LUMEN CATHETER FOR THE PURPOSE OF ADMINISTERING NUTRITION. IT WAS REPORTED THAT THE AREA AROUND THE JUNCTION BETWEEN THE THIN AND THICK PARTS OF THE CATHETER EXPANDED DURING DRUG SOLUTION WAS ADMINISTERED. FURTHERMORE, THE LEAK WAS NOTED AND APPEARS TO BE INTERNAL, THE DEVICE WAS REPLACED WITH ANOTHER DEVICE.

  Patient problems: Extravasation

  MAUDE report 22724035 ↗
• InjuryJul 4, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT USING BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. DURING THE PROCEDURE, THE CATHETER BROKEN NEAR BY THE HUB AREA AND DID NOT FEEL ANY KIND OF COMPRESSION OR PRESSURE WHILE INFUSING. THE DEVICE WAS REMOVED. REPORTEDLY, BROVIAC LINE WAS ALLEGEDLY FOUND COMPLETE BREAK AND ONE LINE WAS WITHIN THE BODY ONLY. THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22401892 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Expulsion; Fluid/Blood Leak; Detachment of Device or Device Component; Expulsion

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND LEAKING. IT WAS FURTHER REPORTED THAT THE CATHETER OUTER LINE WAS PEELED APART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392720 ↗