Broviac 0600100Recalls & reported problems
Bard Access Systems, Inc. · Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant
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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741051708), received between Jul 19, 2018 and Nov 3, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (1 report).
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.
Reports received per month
Recalls naming this device
- Dec 12, 2025Open, Classified
Due to damage to outer tray that can potentially compromise the sterile barrier
Z-1367-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Infuse1
- Fluid/Blood Leak1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of or Failure to Bond1
- Material Puncture/Hole1
- Migration1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Migration
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CATHETER. ON (B)(6) 2025, POST A PROCEDURE AN ACCIDENTAL DISLODGEMENT OF THE BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F OCCURRED. UPON EXAMINING THE CUFF SECTION OF THE DISLODGED CATHETER, IT APPEARS THAT ALMOST NO INGROWTH INTO THE SUBCUTANEOUS TISSUE WAS OBSERVED. 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 23447500 ↗MalfunctionFeb 1, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT APPROXIMATELY SIX MONTH POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A HOLE IN THE THICK PART AND FLUID LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11259040 ↗MalfunctionFeb 1, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE CATHETER ALLEGEDLY SHORTENED OVER THE OUTER SECTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11258543 ↗MalfunctionJul 19, 2018Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO FLUSH THE CATHETER PRIOR TO INSERTION AND RESISTANCE WAS FELT IN THE LUMEN AND THE CATHETER COULD NOT BE FLUSHED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7702849 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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