BroviacRecalls & reported problems across all models

We found 12 models of Broviac by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 615 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2015 and Sep 21, 2026 — classified as 2 deaths, 71 injuries, 542 malfunctions.

The most frequently reported specific device problem is “Fracture” (201 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Broviac recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 5 of these models · Recall details · FDA record ↗

2. 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 · names 3 of these models · Recall details · FDA record ↗

Most reported Broviac problems

Broviac models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Broviac 0600520

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall265 reports
• Broviac 0600540

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall113 reports
• Broviac 0601610

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall67 reports
• Broviac 0600060

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall1 death33 reports
• Broviac 0601620

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall29 reports
• Broviac 0600040

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  64 reports
• Broviac 0600120

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall6 reports
• Broviac 0601600

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall5 reports
• Broviac 0600100

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall4 reports
• Broviac 0600524

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 death17 reports
• Broviac 0600544

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  8 reports
• Broviac 0600044

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  4 reports

Recent Broviac adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 2, 2026Fracture

  A patient underwent a central venous catheter placement procedure using Broviac CV Catheter. After some time, it was reported that the connector was broken. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560485 ↗
• 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 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole

  On (b)(6) 2018, a patient underwent a chronic catheter placement procedure using the Broviac Central Venous Catheter. On (b)(6) 2026, there was a pinhole noted and it caused a fluid leak. The catheter was removed on the same day. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191458 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak; Fracture

  THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. AFTER SOME TIME, THE BROVIAC CATHETER WAS FOUND TO BE BROKEN AND LEAKING, WHICH NECESSITATED THE USE OF A REPAIR KIT. REPORTEDLY, THE CATHETER WAS REPLACED COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906947 ↗
• 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 ↗

Other Bard Access Systems, Inc. products

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