BardPortRecalls & reported problems across all models
Bard Access Systems, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 156
- Deaths reported
- 4
- Injuries reported
- 75
- Recalls
- 0
We found 13 models of BardPort by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Aug 17, 2026 — classified as 4 deaths, 75 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Fracture” (50 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 BardPort problems
Device problems
- Fracture50
- Adverse Event Without Identified Device or Use Problem34
- Material Separation28
- Migration23
- Fluid/Blood Leak15
- Break12
- Disconnection11
- Detachment of Device or Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient28
- Unspecified Infection28
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
- Foreign Body In Patient15
- Thrombosis/Thrombus14
- Pain5
- Sepsis5
BardPort models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BardPort 0606100PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death51 reports
- BardPort 0602230PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR26 reports
- BardPort 0602190PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR17 reports
- BardPort 0602870PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death17 reports
- BardPort 0604970PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death15 reports
- BardPort 0602270PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR8 reports
- BardPort 0603006PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 reports
- BardPort 0602180PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- BardPort 0602240PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- BardPort 0602290PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- BardPort 0602260PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death2 reports
- BardPort 0602280PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- BardPort 0606200PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent BardPort adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathAug 17, 2026Device Appears to Trigger Rejection; Migration
It was reported through the litigation process that, sometime after the port placement, the device allegedly migrated. Additionally, the patient was diagnosed with an unspecified infection and thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 50269245 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2006, A PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN USING A BARDPORT TITANIUM DOME IMPLANTABLE PORT FOR THE TREATMENT OF CROHNS DISEASE. APPROXIMATELY ONE YEAR, EIGHT MONTHS, AND TWENTY NINE DAYS LATER, ON (B)(6) 2007, THE PATIENT WAS DIAGNOSED WITH POSITIVE BLOOD CULTURES AND AN INFECTED PORT A CATH. SUBSEQUENTLY, ON (B)(6) 2007, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25632442 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN FOR CHEMOTHERAPY IV ACCESS RELATED TO CANCER OF THE TONGUE. APPROXIMATELY TWO MONTHS AND FOUR DAYS LATER, ON OR ABOUT (B)(6) 2015, THE PATIENT TESTED POSITIVE FOR METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) AND WAS DIAGNOSED WITH SEVERE SEPSIS AND A PORT A CATH INFECTION. THE PORT WAS SUBSEQUENTLY REMOVED ON THE SAME DAY. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Sepsis; Unspecified Infection
MAUDE report 25390589 ↗DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 24726864 ↗MalfunctionMar 18, 2026Difficult to Flush
ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE PERITONEAL PORT. DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE COULD NOT BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629360 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24589159 ↗MalfunctionMar 9, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT MALFUNCTIONED AND THE CATHETER ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543696 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24543502 ↗MalfunctionFeb 3, 2026Fluid/Blood Leak; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY LEAKED AND SUBSEQUENTLY FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243131 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23825504 ↗MalfunctionDec 9, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754789 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23736093 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23713337 ↗InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23671291 ↗MalfunctionNov 21, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23614513 ↗
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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