BardPort, ChronoFlexRecalls & 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
- 28
- Deaths reported
- 2
- Injuries reported
- 10
- Recalls
- 0
We found 5 models of BardPort, ChronoFlex by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Mar 26, 2026 — classified as 2 deaths, 10 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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, ChronoFlex problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Fracture5
- Fluid/Blood Leak4
- Obstruction of Flow4
- Device Appears to Trigger Rejection3
- Component Missing2
- Deformation Due to Compressive Stress2
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Thrombosis/Thrombus6
- No Consequences Or Impact To Patient5
- Unspecified Infection5
- Sepsis3
- No Patient Involvement2
- Obstruction/Occlusion2
- Swelling/ Edema2
BardPort, ChronoFlex models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BardPort, ChronoFlex 0605510PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death13 reports
- BardPort, ChronoFlex 0605320PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death11 reports
- BardPort, ChronoFlex 0607301PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- BardPort, ChronoFlex 0605490PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- BardPort, ChronoFlex 0607302PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent BardPort, ChronoFlex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathMar 26, 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 24695679 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 23886373 ↗DeathDec 12, 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. REPORTEDLY THE PATIENT EXPIRED.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 23786844 ↗InjuryNov 26, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH THROMBOSIS AND OCCLUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 23655500 ↗MalfunctionOct 15, 2025Migration; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY MIGRATED. 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 23298904 ↗MalfunctionAug 28, 2025Disconnection; Disconnection
ON (B)(6) 2012, THE DEVICE WAS IMPLANTED. IT WAS REPORTED THAT POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY FOUND DISCONNECTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910564 ↗MalfunctionJul 23, 2025Peeled/Delaminated; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Peeled/Delaminated; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material
ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING CHRONO TITANIUM PORT. DURING PREPARATION OF THE PROCEDURE IT WAS NOTED THAT, THE PACKAGING WAS STUCK TO THE INNER PACKAGING, WHICH CAUSED THE DEVICE TO LOSE ITS STERILITY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574214 ↗InjuryJun 25, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 22326603 ↗InjuryMay 16, 2025Device Appears to Trigger Rejection; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Obstruction of Flow; Adverse 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Bacterial Infection; Sepsis; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 22033295 ↗InjuryNov 19, 2024Device Appears to Trigger Rejection; Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER WAS ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED WITH INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia; Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 20720550 ↗InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 20663149 ↗InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED WITH SEPSIS AS A RESULT OF THE DEFECTIVE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 19736712 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY SIX MONTHS AND EIGHT DAYS POST PORT PLACEMENT PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF SEPSIS AND ACUTE ENCEPHALOPATHY. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND THE DEVICE WAS REMOVED. THE STUDY WAS WITHDRAWAL DUE TO THE SUBJECT WAS EXPIRED. THE PRIMARY CAUSE OF THE DEATH WAS LUNG CANCER AND THE DEATH WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE.
Patient problems: Encephalopathy; Sepsis
MAUDE report 18786919 ↗MalfunctionMay 16, 2023Material Discolored; Difficult to Remove; Material Discolored; Difficult to Remove
IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS SUTURED TO THE VESSEL AND LEFT IT IN THE PATIENT BODY DUE TO THE RESISTANCE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16937360 ↗MalfunctionJan 13, 2023Fracture; Suction Problem; Fracture; Suction Problem
IT WAS REPORTED THAT TEN DAYS POST PORT PLACEMENT PROCEDURE VIA LEFT SUBCLAVIAN, THE PUNCTURE NEEDLE WAS ALLEGEDLY NOT VACUUMING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16155784 ↗
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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