Broviac 0600060Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741051692), received between Nov 17, 2015 and Apr 17, 2026 — classified as 1 death, 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 33 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 11, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT FLUID WAS LEAKING OUT OF THE INNER CYLINDER SIDE OF THE DUPLEX DURING THE PROCESS. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21580438 ↗
• MalfunctionSep 1, 2024Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE DOWN OVER TIME. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTER PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115474 ↗
• MalfunctionJun 17, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, WHILE DISSECTING THE CUFF, THE CATHETER ALLEGEDLY GOT DAMAGED AND GOT BROKEN DURING REMOVAL. REPORTEDLY, PATIENT REQUIRED SURGERY TO REMOVE THE FRAGMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546008 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325258 ↗
• MalfunctionNov 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT SIX DAYS POST CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117013 ↗
• MalfunctionJul 17, 2023Difficult to Flush; Fracture; Obstruction of Flow; Difficult to Flush; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A BREAK AT THIN/THICK JUNCTURE. IT WAS FURTHER REPORTED THAT RESISTANCE WAS ALLEGEDLY FELT/OCCLUSION ALARMS FROM PUMP PRIOR TO BREAKS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332163 ↗
• MalfunctionJul 17, 2023Difficult to Flush; Fracture; Obstruction of Flow; Difficult to Flush; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A BREAK AT THIN/THICK JUNCTURE. IT WAS FURTHER REPORTED THAT THE RESISTANCE WAS ALLEGEDLY FELT AND OCCLUSION ALARMS FROM PUMP PRIOR TO BREAKS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331914 ↗
• MalfunctionJul 17, 2023Break; Fracture; Stretched; Material Protrusion/Extrusion; Break; Fracture; Stretched; Material Protrusion/Extrusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331855 ↗
• MalfunctionJul 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266378 ↗
• MalfunctionJul 6, 2023Break; Fracture; Break; Fracture

  HOLD FOR JF 7.6. IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266377 ↗
• MalfunctionJul 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264549 ↗
• MalfunctionJun 30, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD HOLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235500 ↗
• MalfunctionMar 31, 2023Loss of or Failure to Bond; Disconnection; Fracture; Material Separation; Loss of or Failure to Bond; Disconnection; Fracture; Material Separation

  IT WAS REPORTED THAT ONE DAY POST CATHETER PLACEMENT, THE OUTER TUBE ALLEGEDLY BECAME DISCONNECTED FROM THE INNER TUBE AT THE JUNCTURE OF THE TWO-TUBE SECTION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658698 ↗
• MalfunctionJul 15, 2022Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND TEN DAYS POST CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN. IT WAS FURTHER REPORTED THAT AN EXAMINATION DEMONSTRATED THAT THE CATHETER WAS ALLEGEDLY BROKEN AT THE EXTERNAL PART. REPORTEDLY CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025673 ↗
• MalfunctionJan 21, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO DAYS POST CATHETER PLACEMENT PROCEDURE, THE LEAK WAS ALLEGEDLY FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315237 ↗
• MalfunctionDec 10, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE MONTH POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD HOLE WITH FLUID LEAKING OUT AT JUNCTION OF THE HUB. IT WAS FURTHER REPORTED THAT DURING CATHETER EXCHANGE IN OPERATING ROOM THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974234 ↗
• MalfunctionOct 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT EIGHT DAYS POST PORT PLACEMENT, THE HUB WAS ALLEGED FOUND TO BE DAMAGED. IT WAS FURTHER REPORTED THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12653323 ↗
• MalfunctionOct 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THIRTY DAYS POST PORT PLACEMENT, SILICON NEAR HUB ALLEGEDLY HAD A SPLIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629563 ↗
• MalfunctionAug 31, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT TWELVE DAYS POST DEVICE IMPLANT, THE CATHETER OF THE KIT WAS ALLEGEDLY DAMAGED. THE DAMAGED SECTION OF THE CATHETER WAS REPAIRED USING A REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391636 ↗
• InjuryAug 17, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST PORT DEVICE PLACEMENT, REDNESS WAS ALLEGEDLY FOUND ALONG THE CATHETER IMPLANTED AREA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12329700 ↗
• MalfunctionNov 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED NEAR CUFF. THE PROCEDURE WAS COMPLETED WITH REINFORCEMENT OF THE CATHETER WITH A CLAMP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10882635 ↗
• DeathApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE HOURS AFTER PORT INSTALLATION AND ANTIBIOTIC TREATMENT IN A FIVE WEEK INFANT WITH A HISTORY OF BRONCHIOLITIS AND ENDOCARDITIS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR COMPRESSION HEMOPERICARDIUM, AND TAMPONADE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPIRED THE NEXT DAY FROM UNFAVORABLE DEVELOPMENT.

  Patient problems: Bradycardia; Death

  MAUDE report 10012417 ↗
• MalfunctionApr 19, 2019Failure to Infuse; Failure to Infuse

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0600060 CHRONIC CATHETER SOME TIME POST INSERTION, THERE WAS ALLEGED RESISTANCE WHEN INFUSING THE CHRONIC CATHETER. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WHOSE AGE, WEIGHT AND GENDER WAS NOT PROVIDED. PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533414 ↗
• MalfunctionApr 18, 2019Break; Defective Component; Break; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 600060 CHRONIC CATHETER EXPERIENCED A BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, SEX, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528896 ↗