Hickman TriFusionRecalls & reported problems across all models
Bard Access Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 5 models of Hickman TriFusion by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2018 and Sep 9, 2026 — classified as 13 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Fracture” (29 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hickman TriFusion problems
Device problems
- Fracture29
- Material Separation15
- Component Missing10
- Defective Component9
- Missing Information7
- Detachment of Device or Device Component6
- Fluid/Blood Leak6
- Deformation Due to Compressive Stress5
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient9
- Pain4
- Hemorrhage/Blood Loss/Bleeding3
- Foreign Body In Patient2
- No Patient Involvement2
- Bacterial Infection1
- Discomfort1
Hickman TriFusion models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hickman TriFusion 0609190Catheter,intravascular,therapeutic,long-term greater than 30 days34 reports
- Hickman TriFusion 0609230Catheter,intravascular,therapeutic,long-term greater than 30 days17 reports
- Hickman TriFusion 0659230Catheter,intravascular,therapeutic,long-term greater than 30 days8 reports
- Hickman TriFusion 0609270Catheter,intravascular,therapeutic,long-term greater than 30 days7 reports
- Hickman TriFusion 0659190Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
Recent Hickman TriFusion adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Material Integrity Problem
A patient was prepped for a chronic catheter placement procedure using the Hickman TriFusion CV Catheter. Prior to the procedure, it was noted the goods were allegedly damaged. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50687611 ↗InjuryJun 19, 2026Device Appears to Trigger Rejection; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2017, A PATIENT UNDERWENT PORT PLACEMENT FOR CHEMOTHERAPY. APPROXIMATELY ONE YEAR, THREE MONTHS AND ELEVEN DAYS LATER, ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND PULMONARY EMBOLISM. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6) 2018. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 25560804 ↗MalfunctionApr 20, 2026Fracture; Material Separation; Deformation Due to Compressive Stress
ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE DEVICE TUNNELLER ALLEGEDLY SNAPPED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921551 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE WHITE PLASTIC PIECE COVERING THE TUNNELER AND CATHETER TIP SLID OFF AND ENTERED THE TUNNEL TRACT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754520 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE WHITE PLASTIC PIECE COVERING THE TUNNELER AND CATHETER TIP SLID OFF AND ENTERED THE TUNNEL TRACT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754367 ↗InjuryMar 3, 2026Fracture; Material Separation; Device Dislodged or Dislocated; Migration
ON (B)(6) 2026, THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE PLASTIC PIECE COVERING THE CONNECTION POINT BETWEEN THE TUNNELER AND THE CATHETER REPORTEDLY SLID OFF THE TUNNELER AND TRAVELED DOWN THE CATHETER BENEATH THE PATIENT¿S SKIN, RESULTING IN A FOREIGN BODY LEFT INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WITH THE TUNNELED LINE. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Discomfort; Foreign Body In Patient
MAUDE report 24495000 ↗MalfunctionJan 13, 2026Decrease in Suction; Restricted Flow rate; Suction Problem; Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. ON (B)(6) 2025, DURING THE PROCEDURE INLET TUBING NOTED TO HAVE AIR MIXED IN WITH BLOOD DURING ASPIRATION. ON (B)(6) 2025, CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050369 ↗MalfunctionDec 16, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CV CATHETER, TRIPLE LUMEN, 12F. POST THE PROCEDURE ON (B)(6) 2025, THE CLAMP WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23813755 ↗MalfunctionJul 22, 2025Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Material Integrity Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT. DURING PREPARATION, IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564133 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21013117 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21013102 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS WERE ALLEGEDLY MISSING IN THE RECEIVED CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21010771 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING THE PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY RECEIVED WITHOUT LABELS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009462 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000857 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000606 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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