Port AccessRecalls & reported problems across all models

We found 11 models of Port Access by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2018 and May 1, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

2 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

Port Access 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.

1. 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-2664-2020 · Root cause: Process control · names 6 of these models · Recall details · FDA record ↗

2. 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-2660-2020 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

Most reported Port Access problems

Port Access models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Port Access AN142075

  Set, administration, intravascular
  1 recall8 reports
• Port Access AN132075

  Set, administration, intravascular
  1 recall4 reports
• Port Access AN162075

  Set, administration, intravascular
  1 recall3 reports
• Port Access AN142010G

  Set, administration, intravascular
  1 recall2 reports
• Port Access AN162075G

  Set, administration, intravascular
  1 recall2 reports
• Port Access AN162010

  Set, administration, intravascular
  1 recall1 report
• Port Access AN142010

  Set, administration, intravascular
  1 recall0 reports
• Port Access AN162010G

  Set, administration, intravascular
  1 recall0 reports
• Port Access AN152075

  Set, administration, intravascular
  1 recall0 reports
• Port Access AN152075G

  Set, administration, intravascular
  1 recall0 reports
• Port Access AS142075

  Non-Coring (Huber) Needle
  2 reports

Recent Port Access adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT SAFESTEP 20G X 0.75IN HUBER NEEDLE WOULD NOT ENGAGE THE SAFETY MECHANISM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057268 ↗
• MalfunctionMay 1, 2026Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT SAFESTEP 20G X 0.75IN HUBER NEEDLE WOULD NOT ENGAGE THE SAFETY MECHANISM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056829 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN, PATIENT ARRIVED FOR SCHEDULED PARACENTESIS. PORTACATH ACCESSED PER PROTOCOL. GOOD BLOOD RETURN NOTED. FLUSH EASILY. ORDERED ALBUMIN WAS CONNECTED TO PORTACATH TUBING. ONCE ALBUMIN STARTED, IT WAS NOTED THAT IT WAS LEAKING FROM THE TUBING. ALL ACCESS SITES WERE CHECKED AND TIGHTENED. RE-FLUSHED TUBING. TUBING CONTINUED TO LEAK ON PATIENT'S SHIRT. A SECOND NURSE CONFIRMED LEAKING FROM THE TUBING. PORTACATH WAS RE-ACCESSED. ALBUMIN ADMINISTERED AS ORDERED. RN SUPERVISOR NOTIFIED. IR PA [INTERVENTIONAL RADIOLOGY PHYSICIAN ASSISTANT] NOTIFIED, NO FURTHER ORDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594037 ↗
• MalfunctionJun 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, WHILE ACCESSING THE PATIENT'S PORT, THE HUBER NEEDLE SET MALFUNCTIONED AS SOON AS I FLUSHED THE LINE. THE FLUSH STARTED TO LEAK FROM THE TOP PIECE (SAFETY LOCK) OF THE HUBER NEEDLE AND WILL NOT DRAW BLOOD BACK FROM THE PORT. DE-ACCESSED HER PORT RIGHT AWAY AND RE ACCESS WITH NEW NEEDLE. PATIENT WAS ABLE TO GET HER TREATMENT, AND NO OTHER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163038 ↗
• MalfunctionJun 3, 2025Misassembled; Misassembled

  IT WAS REPORTED BY THE CUSTOMER THERE WAS NO SLEEVE COVERING THE HUBER NEEDLE. THE HCP SUFFERED A NEEDLE STICK WHILE ATTACHING THE CLAVE AND STERILE FLUSH. THE DEVICE WAS DISPOSED OF AFTER THE EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22135077 ↗
• MalfunctionMar 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HAIR IN THE PORT ACCESS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602146 ↗
• MalfunctionJun 7, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD TWO INSTANCES THIS WEEK WHERE THE PORT NEEDLE EITHER COMPLETELY STUCK AND WAS NOT ABLE TO BE RETRACTED OR VERY STIFF AND WAS DIFFICULT TO RETRACT WHEN DE-ACCESSING FROM PORTS. REMOVED FROM PATIENT WITHOUT ENGAGING SIMULTANEOUSLY. THERE WAS NO DELAY OR COMPROMISE IN PATIENT CARE. THERE WAS NO ADVERSE EVENT OR OUTCOME. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490858 ↗
• MalfunctionJun 7, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD TWO INSTANCES THIS WEEK WHERE THE PORT NEEDLE EITHER COMPLETELY STUCK AND WAS NOT ABLE TO BE RETRACTED OR VERY STIFF AND WAS DIFFICULT TO RETRACT WHEN DE-ACCESSING FROM PORTS. REMOVED FROM PATIENT WITHOUT ENGAGING SIMULTANEOUSLY. THERE WAS NO DELAY OR COMPROMISE IN PATIENT CARE. THERE WAS NO ADVERSE EVENT OR OUTCOME. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484053 ↗
• MalfunctionMar 2, 2023Crack; Crack

  IT WAS REPORTED, PICC NURSES HAD PORT-NEEDLES THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUBS WERE CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16475510 ↗
• MalfunctionMar 2, 2023Crack; Crack

  IT WAS REPORTED, PICC NURSE HAD PORT-NEEDLE THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUB WAS CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 16475502 ↗
• MalfunctionMar 2, 2023Crack; Crack

  IT WAS REPORTED, PICC NURSES HAD PORT-NEEDLES THAT NEEDED REPLACEMENT DUE TO LEAKING, IT APPEARS HUBS WERE CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16475495 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "A TEGADERM DRESSING IS APPLIED TO THE PORT, BUT THE DISTAL END OF THE LINE WHERE IT MEETS THE CLAVE IS WHERE THE BREAK IS OCCURRING AND THIS PORTION HANGS DOWN BELOW THE DRESSING. OCCURRED IN PEDIATRIC DEPARTMENT."

  Patient problems: Insufficient Information

  MAUDE report 15763356 ↗
• MalfunctionMay 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "FOUND A PORT NEEDLE THAT LOOKS LIKE THE PLASTIC HOUSING IS CRACKED. IT WAS LEAKING BOTH BLOOD AND FLUIDS UPON FLUSHING AND ASPIRATION." ADD INFO RCVD 05/11/2022: WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465991 ↗
• InjuryJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAVE A 3 YEAR OLD THAT NOW HAS HAD 2 TUBING FRACTURES WITH THE POWER NEEDLE IN THE ALL POINTS KITS AND UNFORTUNATELY HE HAS A CONFIRMED CLABSI. RL¿S HAVE BEEN PLACED AND ONE OF THE NEEDLES WAS SENT TO VALUE ANALYSIS." THIS REPORT ADDRESSES THE DEVICE THAT WAS SAVED AND SENT TO VALUE ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 12181022 ↗
• InjuryJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAVE A (B)(6) YEAR OLD THAT NOW HAS HAD 2 TUBING FRACTURES WITH THE POWER NEEDLE IN THE ALL POINTS KITS AND UNFORTUNATELY HE HAS A CONFIRMED CLABSI. RL¿S HAVE BEEN PLACED AND ONE OF THE NEEDLES WAS SENT TO VALUE ANALYSIS." THIS REPORT ADDRESSES THE DEVICE THAT WAS NOT SENT TO VALUE ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 12181021 ↗

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