Port Access KitRecalls & reported problems across all models
Bard Access Systems, Inc. · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 4
We found 49 models of Port Access Kit by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2016 and Sep 15, 2026 — classified as 5 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (38 reports).
4 FDA recall records name at least one of these models by its device identifier.
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
Port Access Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2668-2020 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2666-2020 · Root cause: Process control · names 15 of these models · Recall details · FDA record ↗
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2663-2020 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2662-2020 · Root cause: Process control · names 16 of these models · Recall details · FDA record ↗
Most reported Port Access Kit problems
Device problems
- Fluid/Blood Leak38
- Crack12
- Activation Problem9
- Loss of or Failure to Bond9
- Material Deformation8
- Detachment of Device or Device Component7
- Contamination /Decontamination Problem5
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient9
- No Patient Involvement4
- Thrombosis3
- Chemical Exposure2
- Anxiety1
- Discomfort1
Port Access Kit models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Port Access Kit 2142075Set, administration, intravascular1 recall28 reports
- Port Access Kit PA-0031Set, administration, intravascular1 recall9 reports
- Port Access Kit PA-0031YNSet, administration, intravascular1 recall7 reports
- Port Access Kit PA-0029YNSet, administration, intravascular1 recall4 reports
- Port Access Kit 2132075Set, administration, intravascular1 recall3 reports
- Port Access Kit PA-0030YNSet, administration, intravascular1 recall2 reports
- Port Access Kit 2141975Set, administration, intravascular1 recall1 report
- Port Access Kit PA-0029Set, administration, intravascular1 recall1 report
- Port Access Kit PA-0032Set, administration, intravascular1 recall1 report
- Port Access Kit 2131910Set, administration, intravascular1 recall0 reports
- Port Access Kit 2131915Set, administration, intravascular1 recall0 reports
- Port Access Kit 2131975Set, administration, intravascular1 recall0 reports
- Port Access Kit 2132015Set, administration, intravascular1 recall0 reports
- Port Access Kit 2132210Set, administration, intravascular1 recall0 reports
- Port Access Kit 2132275Set, administration, intravascular1 recall0 reports
- Port Access Kit 2141910Set, administration, intravascular1 recall0 reports
- Port Access Kit 2141915Set, administration, intravascular1 recall0 reports
- Port Access Kit 2142010Set, administration, intravascular1 recall0 reports
- Port Access Kit 2142015Set, administration, intravascular1 recall0 reports
- Port Access Kit 2142210Set, administration, intravascular1 recall0 reports
- Port Access Kit 2142215Set, administration, intravascular1 recall0 reports
- Port Access Kit 2142275Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0030Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0032YNSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0033Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0033YNSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0034Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0034YNSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0036Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0038Set, administration, intravascular1 recall0 reports
- Port Access Kit PA-0038YNSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0031GSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0031YNGSet, administration, intravascular1 recall0 reports
- Port Access Kit 2142010GSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0032GSet, administration, intravascular1 recall0 reports
- Port Access Kit 2132010GSet, administration, intravascular1 recall0 reports
- Port Access Kit 2132015GSet, administration, intravascular1 recall0 reports
- Port Access Kit 2141910GSet, administration, intravascular1 recall0 reports
- Port Access Kit PA-0033GSet, administration, intravascular1 recall0 reports
- Port Access Kit 2682034Set, administration, intravascular10 reports
- Port Access Kit 2682010Set, administration, intravascular7 reports
- Port Access Kit 2652034PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 reports
- Port Access Kit 2672010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- Port Access Kit 2671910PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Port Access Kit 2132010Set, administration, intravascular1 report
- Port Access Kit 2632034Set, administration, intravascular1 report
- Port Access Kit 2632234PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Port Access Kit 2652010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- Port Access Kit 2672034PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent Port Access Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776470 ↗MalfunctionApr 23, 2026Fluid/Blood Leak; Material Deformation
IT WAS REPORTED BY MEDWATCH THE PATIENT CAME TO CLINIC FOR VENOFER INFUSION. PATIENT'S PORT WAS ACCESSED. PATIENT WAS ABOUT AN 1.5 HOURS INTO THE VENOFER INFUSION WHEN A SMALL AMOUNT OF LIQUID WAS NOTED ON HIS SHIRT. THE LEAKING WAS COMING FROM WHERE THE CLAVE CONNECTS TO THE PORT ITSELF. PATIENT WAS FINISHED WITH THE VENOFER AND SALINE WAS INFUSING FOR THE NEXT 30 MINUTES. THE TUBING WAS WRAPPED WITH GAUZE WITH MINIMAL DRAINAGE. PORT WAS THEN DE-ACCESSED. NO FURTHER ISSUES NOTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966308 ↗MalfunctionApr 23, 2026Loss of or Failure to Bond
IT WAS REPORTED BY CUSTOMER THAT DRESSING IN THE KIT IS NOT ADHERING TO THE PATIENTS RIGHT AFTER APPLICATION. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966307 ↗MalfunctionApr 16, 2026Loss of or Failure to Bond
CUSTOMER REPORTED THE DRESSING DOES NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901834 ↗MalfunctionApr 6, 2026Loss of or Failure to Bond
IT WAS REPORTED ALL 50 OF THE KITS ARE BEING SENT WITH A DRESSING THAT NO LONGER ADHERES TO THE PATIENT. CUSTOMER SAID NURSES ARE ALL USING SKIN PREP LIKE THEY ALWAYS DO AND THEY WON'T STICK. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL FIFTY KITS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791157 ↗MalfunctionMar 25, 2026Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THIS MORNING THERE WAS A LEAK AT THE EXTENSION LINE CONNECTING TO THE CLAVE. CLAVE CHANGED OUT AND COULD NOT SEE ANY LEAKING AT FIRST. THEN, LEAKING DID OCCUR. PATIENT GETTING HYDRATION AND ELECTROLYTES INFUSED. STOPPED INFUSION, DE-ACCESSED AND THEN RE-ACCESSED PATIENT WITH NEW PORT, DIFFERENT LOT NUMBERS, AND NO ISSUES AT THIS TIME. RESULTED IN THE NEED FOR INCREASED MONITORING NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24683380 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE WHEN THE IV LINE/MEDICATION WAS HOOKED UP TO THE PATIENT, THE CONNECTOR STARTED TO LEAK. THE CONNECTOR WAS THEN REPLACED THREE TIMES WITH THE SAME RESULTS. THE PORT NEEDLE WAS THEN DE-ACCESSED AND RE-ACCESSED WITH A NEW NEEDLE. THIS RESOLVED THE PROBLEM AND THERE WAS NO MORE LEAKING. THE FLUIDS THAT LEAKED WERE NOT CHEMOTHERAPY, JUST NS AND SOME ANTINAUSEA MEDICATION. REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575330 ↗MalfunctionMar 10, 2026Fluid/Blood Leak; Product Quality Problem
IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKING OCCURRED AT THE CONNECTOR SITE. AFTER STARTING HYDRATION ON PATIENT VIA PORT, LEAKING OCCURRED AT THE CONNECTOR SITE. REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565286 ↗MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED THAT WHILE RUNNING HYDRATION IT AS NOTICED PORT TUBING WAS LEAKING ABOVE CLAVE CONNECTION POINT NO MATTER HOW TIGHT THE CLAVE WAS. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565283 ↗MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED PATIENT WAS RUNNING GEMZAR AND WHILE IN THE BATHROOM SHE NOTICED DRIPS ON THE FLOOR, CHEMO AND NS WERE STOPPED. CHEMO TUBING WAS LEAKING FROM THE BLUE LOADING PIECE ABOVE THE PUMP SEGMENT OF TUBING. PATIENT WAS DISCONNECTED AND A SPILL KIT WAS USED TO CLEAN UP PUMP AND BATHROOM; NONE REACHED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559407 ↗MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED PATIENT CAME TO CLINIC FOR ABRAXANE INFUSION VIA PORT. PATIENT'S PORT WAS ACCESSED. NO LEAKING NOTED DURING THE INFUSION, BUT WITH FLUSHING THE PORT AFTER THE INFUSION, IT WAS NOTED THAT FLUID WAS LEAKING WHERE THE CLAVE CONNECTS ON TO THE END OF THE PORT TUBING. THE LEAKING ONLY HAPPENED WITH FLUSHING THE PORT WITH SALINE, NOT DURING THE CHEMO TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559255 ↗MalfunctionFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS RUNNING 24-HOUR METHOTREXATE AND WAS APPROXIMATELY 20 HOURS INTO INFUSION (WITH SODIUM BICARBONATE FLUIDS RUNNING AT THE SAME TIME). PARENT PRESSED CALL LIGHT AND REPORTED THAT THE PATIENT'S IMPLANTED PORT WAS HURTING HER. RN PAUSED METHOTREXATE AND SODIUM BICARBONATE AND ASSESSED THE PORT SITE. THE DRESSING WAS TAUGHT DUE TO LOCALIZED EDEMA AT THE SITE, AND THE PATIENT'S SHIRT WAS WET OVER THE SITE. IT WAS SUSPECTED TO BE INFILTRATED AND THE PROVIDER CAME AND ASSESSED AND AGREED. PORT WAS DE-ACCESSED AND HEAT WAS APPLIED TO THE SITE.
Patient problems: Extravasation; Pain; Swelling/ Edema
MAUDE report 24337635 ↗MalfunctionNov 20, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED IMMEDIATELY AFTER PERFORMING A NEEDLELESS CONNECTION DEVICE CHANGE ON A HUBER NEEDLE WHEN FLUSHING THE LINE SALINE WAS LEAKING, SO ANOTHER CONNECTOR WAS PLACED, AND THE LEAK WAS STILL PRESENT. AFTER THAT IT WAS SURMISED THAT THE DISTAL CONNECTION ON THE HUBER NEEDLE TUBING WAS DAMAGED. THE HUBER NEEDLE WAS CHANGED AFTER THAT, AND THE CONNECTOR WAS CRACKED. THIS HUBER NEEDLE WAS PLACED ON TUESDAY, 10/28, AND HAS HAD THE NEEDLELESS CONNECTOR CHANGED EVERY 12 HOURS BECAUSE PROPOFOL HAS BEEN BEING INFUSED THROUGH THAT LINE. THE ISSUE OF LEAKING HAS NEVER BEEN NOTICED UNTIL THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605847 ↗MalfunctionJul 31, 2025Material Deformation; Material Deformation
IT WAS REPORTED, PATIENT ARRIVED TO OUTPATIENT INFUSION CLINIC TO HAVE THEIR 5-FU PUMP REMOVED AND CENTRAL VENOUS ACCESS SITE FLUSHED. PATIENT ARRIVED TO INFUSION SUITE VIA AMBULATION AND DENIED COMPLAINTS AT THIS TIME. 5FU PUMP BALL APPEARS DEFLATED. PUMP DISCONNECTED AND LINE FLUSHED WITH 20ML NS PER PROTOCOL WITHOUT INCIDENT. WHILE RN ATTEMPTED TO DE-ACCESS PORT HUBER NEEDLE; RESISTANCE WAS NOTED TOWARD THE END OF THE NEEDLE AND PATIENT VERBALIZED EXTREME DISCOMFORT. HEALTHCARE PROFESSIONAL CAME TO CHAIRSIDE TO EVALUATE; PER NP, "GO TO THE EMERGENCY DEPARTMENT." PATIENT VERBALIZED UNDERSTANDING AND AGREED TO GO TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. PORT SITE + HUBER NEEDLE STABILIZED WITH GAUZE ABD DRESSING + TAPE. ED NOTIFIED VIA TELEPHONE OF PATIENT'S CONDITION. PATIENT LEFT INFUSION SUITE INDEPENDENTLY WITH STEADY GATE. NURSES EXPLAINED THAT PATIENT SAID THAT HE ROLLED ON THE NEEDLE WHEN SLEEPING. CAME INTO HOSPITAL WITH THE PORT NEEDLE LOOKING TO BE ALMOST PULLED OUT AND EXPERIENCED INTENSE DISCOMFORT WHEN DE-ACCESSING.
Patient problems: Discomfort
MAUDE report 22677286 ↗MalfunctionJul 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED OUTPATIENT INFUSION UNIT OPENED A BRAND-NEW STERILE PORT KIT AND FOUND A HAIR IN THE KIT AS SOON AS IT WAS OPENED. WE WERE UNABLE TO USE THIS KIT DUE TO ITS COMPROMISED STERILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577779 ↗
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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