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Broviac 0601600Recalls & reported problems

Bard Access Systems, Inc. · 2.7F Broviac CV Catheters 0.5 mm Lumen (White Adapter) Repair Kit · Class 2

All models of Broviac (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741036378), received between Sep 14, 2016 and Apr 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. 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 · Recall details · FDA record ↗

Most reported problems

Device problems

  • Fracture4
  • Burst Container or Vessel2
  • Fluid/Blood Leak2
  • Break1
  • Expulsion1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Code Available1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2023Fracture; Fracture

    IT WAS REPORTED THAT SOMETIME POST REPAIR KIT CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16727574 ↗
  • MalfunctionApr 12, 2023Fracture; Fracture

    IT WAS REPORTED THAT SOMETIME POST REPAIR KIT CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16723356 ↗
  • MalfunctionNov 9, 2021Burst Container or Vessel; Fluid/Blood Leak; Fracture; Expulsion; Burst Container or Vessel; Fluid/Blood Leak; Fracture; Expulsion

    IT WAS REPORTED THAT ONE MONTH POST CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY NOTED TO BE BROKEN AND LEAKING. IT WAS FURTHER REPORTED THAT THE CUFF OF THE DEVICE EXPOSED. THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12777468 ↗
  • MalfunctionNov 9, 2021Burst Container or Vessel; Fluid/Blood Leak; Fracture; Burst Container or Vessel; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY NOTED TO BE BROKEN AND LEAKING. THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12777466 ↗
  • MalfunctionSep 14, 2016Break; Leak/Splash

    ON (B)(6) 2016 IT WAS REPORTED BY FACILITY THAT A PATIENT HAD A BROKEN CATHETER AND WAS PRESENTED TO THE ED FOR REPAIR. IT WAS STATED THAT THE REPAIR WAS ATTEMPTED, SITE WAS STABILIZED, BUT THE LINE CONTINUED TO LEAK WITH GENTLE/SMALL FLUSHING AND THEY WERE UNABLE TO DRAW BLOOD DESPITE REPAIR. THE PATIENT WAS ADMITTED FOR THE ADMINISTERING OF TPN AND A NEW CATHETER WAS PLACED. NO PATIENT HARM REPORTED.

    Patient problems: No Code Available

    MAUDE report 5949459 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources and updates

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