Broviac 0600120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741051715), received between Nov 20, 2015 and Oct 24, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Burst Container or Vessel; Difficult to Flush; Fracture; Material Puncture/Hole; Burst Container or Vessel; Difficult to Flush; Fracture; Material Puncture/Hole

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE BROVIAC CV CATHETER. THE PRODUCT WAS PLACED IN THE PATIENT'S BODY. AFTER 28 DAYS POST THE PROCEDURE, IT WAS NOTED THAT THE FLUSHING WAS NOT SMOOTH, AND AFTER REMOVING IT USING SURGERY, IT WAS FOUND THAT THE TUBE WAS RUPTURED. ADDITIONALLY, ONLY ONE HOLE WAS NOTED. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377311 ↗
• MalfunctionAug 1, 2022Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST CATHETER PLACEMENT PROCEDURE, CATHETER ALLEGEDLY DAMAGED BY SCRATCHING. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED SKIN REACTIONS DUE TO DRESSINGS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137279 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND ELEVEN MONTHS POST CATHETER PLACEMENT PROCEDURE, THE PLASTIC HUB AT THE END OF THE LINE ALLEGEDLY GOT SEPARATED AND COULD NOT BE PUSHED BACK TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234338 ↗
• MalfunctionJul 17, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600120 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A CRACK IN THE CATHETER. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION HAD PATIENT INVOLVEMENT BUT THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291575 ↗
• InjuryNov 7, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN DAYS POST CHRONIC CATHETER PLACEMENT FOR TOTAL PARENTERAL NUTRITION (TPN), THERE WAS ALLEGEDLY LOW FLOW RATE IN THE CATHETER. REPORTEDLY, IMAGING DEMONSTRATED GOOD BLOOD FLOW, NO KINKING OF THE CATHETER, AND VERIFIED CATHETER TIP POSITION. IT WAS FURTHER REPORTED THE CATHETER WAS REMOVED AND REPLACED. THE PATIENT WAS IN THE HOSPITAL FOR A PROLONGED PERIOD OF TIME DUE TO THE TESTS AND CATHETER REPLACEMENT. THE PATIENT WAS DISCHARGED AND IS STABLE POST CATHETER REMOVAL AND REPLACEMENT.

  Patient problems: Injury

  MAUDE report 9291232 ↗
• MalfunctionNov 20, 2015Torn Material

  "PHONE CALL FROM PATIENT TO SAY NOTICED LINE HAD ALLEGED TEAR 5MM IN LENGTH ABOVE COLLAR ON LINE. THIS WAS NOTED IN THE MORNING POST DISCONNECTION, NIL LEAKING FROM LINE NOTED BY PATIENT. IT WAS DECIDED TO REPAIR THE LINE DESPITE NO LEAKING AS IT WOULD EVENTUALLY LEAK. PRE-REPAIR FLUSHED AND NO LEAKING EVIDENT. LINE EXTERNAL SECUREMENT IS IV 3000 BIOCLUSIVE DRESSING; PRIMARY PURPOSES FOR INSERTION OF THE CATHETER WAS FOR TPN. SITE WAS VERY STICKY WITH YELLOW COLOURED SUBSTANCE ADHERED TO THE LINE, SKIN WAS VERY BLACK AND STICKY. LINE AND SKIN CLEANED THOROUGHLY. CATHETER WAS REPAIRED AND FLUSHED WITH NORMAL SALINE, NIL LEAKING POST REPAIR. ADVISED NOT TO USE LINE 12 HOURS POST REPAIR. UPON VISUAL EXAMINATION IN THE LABORATORY THESE APPEARED TO BE A SPLIT IN THE LINE APPROXIMATELY 3CM FROM THE COLLAR. THE DEFECTIVE DEVICE WAS THEN ATTACHED TO A SYRINGE FILLED DEIONISED WATER AND THE WATER WAS PASSED DOWN THE LINE, NO LEAKAGE NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5241212 ↗