Broviac 0600540Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00801741051821), received between Nov 10, 2015 and Sep 2, 2026 — classified as 14 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Fracture” (39 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 113 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJan 9, 2026Difficult to Flush; Suction Problem; Obstruction of Flow

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2025, POST THE PROCEDURE CLOGS WAS NOTED WITHIN 02 TO 03 WEEKS WITH EPO-PLASTINOL. ADDITIONALLY, THERE WAS AN ISSUE WITH FLUSHING AND ASPIRATION. CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018429 ↗
• MalfunctionDec 2, 2025Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress; Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F. DURING THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE DILATOR NOT GLIDING ON GUIDEWIRE AND DILATOR SHEATH TIP ALLEGEDLY BROADENED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691070 ↗
• MalfunctionDec 2, 2025Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress; Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F. DURING THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE DILATOR NOT GLIDING ON GUIDEWIRE AND DILATOR SHEATH TIP ALLEGEDLY BROADENED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691065 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER. PRIOR TO PROCEDURE THE PACKAGE WAS ALLEGEDLY FOUND WITH FOREIGN OBJECTS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276255 ↗
• MalfunctionAug 19, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN S/L CATHETERS. ON (B)(6) 2025, IT WAS REPORTED THAT POST PLACEMENT PROCEDURE, THERE WAS A CRACK IN THE DEVICE. THE BROKEN CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837403 ↗
• MalfunctionJul 24, 2025Loss of or Failure to Bond; Expulsion; Loss of or Failure to Bond; Expulsion

  ON (B)(6) 2024, A PATIENT UNDERWENT THE MULTIPLE HICKMAN LINE WAS INSERTED. ON AUG 23,2024, IT WAS REPORTED THAT POST PLACEMENT PROCEDURE THE CUFF WAS ALLEGEDLY NOTICED TO BE AT EXIT SITE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584417 ↗
• MalfunctionJul 23, 2025Loss of or Failure to Bond; Expulsion; Migration; Loss of or Failure to Bond; Expulsion; Migration

  ON (B)(6) 2024, A PATIENT UNDERWENT THE MULTIPLE HICKMAN LINE WAS INSERTED. ON (B)(6) 2024, IT WAS REPORTED THAT POST PLACEMENT PROCEDURE THE LINE WAS ALLEGEDLY RE-X RAYED. REPORTEDLY THE LINE FOUND TO HAVE MIGRATED OUT TIP LYING IN BRACHIOCEPHALIC VEIN DESPITE ANCHORING SUTURE AT EXIT SITE. THE LINE REPLACEMENT WAS REQUIRED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573961 ↗
• InjuryJul 23, 2025Loss of or Failure to Bond; Expulsion; Migration; Loss of or Failure to Bond; Expulsion; Migration

  ON (B)(6) 2024, A PATIENT UNDERWENT THE MULTIPLE HICKMAN LINE WAS INSERTED. ON (B)(6) 2025, IT WAS REPORTED THAT POST PLACEMENT PROCEDURE THE CUFF WAS ALLEGEDLY NOTICED TO BE MIGRATED 2CM. IT WAS FURTHER REPORTED THAT THE ANCHOR SUTURE WAS REMOVED. THE LINE REPLACEMENT WAS REQUIRED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22573759 ↗
• MalfunctionJun 5, 2025Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER APPROXIMATELY SIX MONTHS AGO. ON (B)(6) 2025, THE CATHETER ALLEGEDLY BROKE. REMOVAL, REPOSITIONING WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147390 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE HUB ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512124 ↗
• MalfunctionFeb 18, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD BALLOONING IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399084 ↗
• MalfunctionJan 13, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER'S CLAMP WAS ALLEGEDLY SLIPPED AND UNCLAMPED ON ITS OWN. IT WAS FURTHER REPORTED THAT A HEMOSTAT FORCEPS WAS USED TO CLAMP THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137874 ↗
• MalfunctionJan 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER'S CLAMP WAS ALLEGEDLY SLIPPED AND UNCLAMPED ON ITS OWN. IT WAS FURTHER REPORTED THAT A HEMOSTAT FORCEPS WAS USED TO CLAMP THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21133081 ↗
• MalfunctionOct 25, 2024Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE LINE ALLEGEDLY MIGRATED. IT WAS FURTHER REPORTED THAT AFTER REINSERTION, SUTURE WAS INTACT BUT THE LINE HAD MIGRATED THROUGH THE STITCH DUE TO LOOSENING. FURTHERMORE, THE CUFF WAS NOT DETACHED AND THE ENTIRE DEVICE HAD PARTIALLY MIGRATED OUT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 20531141 ↗
• InjuryOct 25, 2024Migration; Migration

  IT WAS REPORTED THAT TWENTY FOUR DAYS POST A CHRONIC CATHETER PLACEMENT, THE LINE ALLEGEDLY MIGRATED AND REQUIRED REINSERTION. REPORTEDLY, THE CATHETER WAS REPLACED TWICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 20531039 ↗
• MalfunctionSep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY COULD HAVE GAVE THE PATIENT AN ALLERGIC REACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20229080 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fracture; Material Integrity Problem; Fluid/Blood Leak; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, DAMAGE WAS ALLEGEDLY OBSERVED ON THE EXTERNAL PART OF THE CATHETER. FLUID LEAKAGE WAS CONFIRMED BY FLUSHING WITH SALINE BEFORE ADMINISTRATION OF THE DRUG. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030926 ↗
• MalfunctionAug 10, 2024Material Discolored; Stretched; Material Protrusion/Extrusion; Material Discolored; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE LEFT SAPHENOUS VEIN, THE BUBBLE WAS ALLEGEDLY FOUND TO BE PRESENT DISTALLY TO THE CLAMP. IT WAS FURTHER REPORTED THAT THE FLUID WAS ASPIRATED WHILE CLAMPED AND BUBBLE DE-INFLATED. FURTHERMORE, THE BLOOD RETURN WAS PRESENT BUT PINK DISCOLORATION WAS ALLEGED FOUND IN THE THIN AREA OF LINE. MOREOVER, THE LINE WAS FLUSHED AND WHEN EXTRA PRESSURE ADDED, NEW BUBBLE ALLEGEDLY FORMED IN THE SAME AREA. EVIDENTLY, ABLE TO REMOVE THE FLUID AGAIN AND FLUSHED SLOWLY WITHOUT FORCE. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957671 ↗
• MalfunctionMay 2, 2024Fracture; Difficult to Insert; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Integrity Problem; Physical Resistance/Sticking; Fracture; Difficult to Insert; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, WHEN THE GUIDEWIRE WAS INSERTED, RESISTANCE WAS ALLEGEDLY FELT AND THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE ADVANCED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE REMOVED. FURTHERMORE, WHEN PULLED BACK, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228261 ↗
• MalfunctionDec 29, 2023Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT APPROXIMATELY A COUPLE OF YEARS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A PINHOLE FRACTURE. IT WAS FURTHER REPORTED THAT THE INFUSION WAS ALLEGEDLY OOZING OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417159 ↗
• MalfunctionNov 27, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD PINHOLE A FEW MILLIMETERS FROM THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207991 ↗
• MalfunctionNov 14, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE INTRODUCER ALLEGEDLY DID NOT OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129549 ↗
• MalfunctionSep 1, 2023Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT NINE DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY DOES NOT HAVE BACK FLOW. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DIFFICULTY IN FLUSHING. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17668894 ↗