Port Access Needle LH-0032YNRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741066238), received between Sep 26, 2018 and Jan 7, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (26 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 19, 2020Class IITerminated

   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-2669-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING NEEDLE HUB REPOSITIONING WHEN FLUSHING WITH NORMAL SALINE, BLOOD SPRAYS OUT FROM THE OTHER END OF THE Y TYPE NEEDLE CONNECTOR OF THE VASCULAR ACCESS. IT IS NOT SEALED, SO THIS ARTIFICIAL VASCULAR NEEDLE HUB MUST BE REMOVED AND REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION PROVIDED (B)(6) 2025, UPON NOTICING INFILTRATION DURING THE NORMAL SALINE INFUSION, THE CATHETER WAS IMMEDIATELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994538 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED WHEN ACCESSING NON-CORING IN PATIENT, LEAKAGE OCCURRED FROM THE CONNECTOR HUB AND WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974047 ↗
• MalfunctionSep 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE WAS NOT LOCKING CORRECTLY AND THE WHITE HUB WAS MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076337 ↗
• MalfunctionAug 25, 2025Backflow; Backflow

  IT WAS REPORTED, SAFETY INJECTION NEEDLE (PORT-A) Y-TYPE NO. 20: WHEN THE LONG NEEDLE'S Y-TYPE CONTACT POINT TOUCHES, BLOOD WILL SEEP OUT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887568 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER LIQUID LEAKAGE FROM THE PLASTIC PLATE DURING INFUSION THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468123 ↗
• MalfunctionMay 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED VIA MEDWATCH THAT WHILE THE REGISTERED NURSE (RN) GATHERED HIS SUPPLIES TO ACCESS THE PATIENT FOR HIS TREATMENT THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE, HE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING, LOOKED LIKE PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. HUBER NEEDLE, END CAP, AND PACKAGING GIVEN TO RN MANAGER. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENTS PORT FOR TREATMENT. NO PATIENT HARM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044208 ↗
• MalfunctionMay 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED; RN GATHERED HER SUPPLIES TO ACCESS THE PATIENT FOR HER TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE, SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942948 ↗
• MalfunctionApr 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "RN GATHERED HER SUPPLIES TO ACCESS THE PATIENT FOR HER TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. WHEN EXAMINING THE WHITE END CAP IT LOOKED LIKE IT HAD A SMALL DIVOT ON IT, LIKE IT WAS MISSING A PIECE OF PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENT PORT FOR TREATMENT. NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915654 ↗
• MalfunctionApr 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "RN GATHERED HER SUPPLIES TO ACCESS THE PATIENT FOR HIS TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE, SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. SHE TURNED THE END OF THE TUBING OVER AND THE TINY WHITE PIECE CAME OUT, IT FELT HARD TO THE TOUCH, QUESTIONING IF IT WAS A PIECE OF PLASTIC. WHEN EXAMINING THE WHITE END CAP, IT LOOKED LIKE IT HAD A SMALL DIVOT ON IT, LIKE IT WAS MISSING A PIECE OF PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENT'S PORT FOR TREATMENT. NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914774 ↗
• MalfunctionApr 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "RN GATHERED HER SUPPLIES TO ACCESS THE PATIENT FOR HER TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. WHEN EXAMINING THE WHITE END CAP IT LOOKED LIKE IT HAD A SMALL DIVOT ON IT, LIKE IT WAS MISSING A PIECE OF PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENT PORT FOR TREATMENT. NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914773 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH RN (REGISTERED NURSE) GATHERED HER SUPPLIES TO ACCESS THE PATIENTS PORT FOR HIS TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE, SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. SHE TURNED THE END OF THE TUBING OVER AND THE TINY WHITE PIECE CAME OUT, IT FELT HARD TO THE TOUCH, QUESTIONING IF IT WAS A PIECE OF PLASTIC. WHEN EXAMINING THE WHITE END CAP, IT LOOKED LIKE IT HAD A SMALL DIVIT ON IT, LIKE IT WAS MISSING A PIECE OF PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. HUBER NEEDLE, END CAP, AND PACKAGING GIVEN TO RN MANAGER. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENTS PORT FOR TREATMENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903857 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH RN GATHERED HER SUPPLIES TO ACCESS THE PATIENT FOR HER TREATMENT. WHEN THE RN TOOK OFF THE WHITE END CAP FROM THE END TUBING OF THE HUBER NEEDLE, SHE NOTED A TINY PIECE OF WHITE ON THE INSIDE OF THE END TUBING. WHEN EXAMINING THE WHITE END CAP, IT LOOKED LIKE IT HAD A SMALL DIVIT ON IT, LIKE IT WAS MISSING A PIECE OF PLASTIC. THESE ITEMS WERE SET ASIDE, NOT USED FOR PORT ACCESS. HUBER NEEDLE, END CAP, AND PACKAGING GIVEN TO RN MANAGER. A DIFFERENT HUBER NEEDLE OBTAINED, NO ISSUES NOTED WITH IT AND WAS USED TO ACCESS THE PATIENTS PORT FOR TREATMENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887239 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "HUBER NEEDLE REMOVED FROM PACKAGING. RN NOTICED A CHIP OF PLASTIC MISSING FROM THE CONNECTOR. PRODUCT NOT USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886754 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHEN RN TOOK THE END CAP OFF THE HUBER NEEDLE, SHE NOTED WHAT LOOKED LIKE A SMALL PIECE OF WHITE PLASTIC DOWN IN THE TUBING PART OF THE HUBER NEEDLE. WHEN LOOKING AT THE INNER PART OF THE END CAP IT LOOKED LIKE THERE WAS A PIECE OF THE PLASTIC MISSING. WE ARE NOT SURE IF THAT PIECE WAS FROM THE END CAP OR NOT, OR IF THAT WAS A DEFECT IN THE END CAP. NO IMPACT TO THE PATIENT, ISSUE WAS NOTED PRIOR TO ACCESSING THE PATIENT¿S PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884730 ↗
• MalfunctionApr 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER A PIECE BROKE OFF THE END CAP ON HUBER NEEDLE LINE. ALL WERE CAUGHT BEFORE USE ON A PATIENT. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754119 ↗
• MalfunctionMar 27, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD SHAVINGS IN 5 PACKS OF THE NEEDLES. CUSTOMER HAD NO ADVERSE REACTION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL FIVE PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713568 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD STAIN WAS PRESENT ON INJECTION HUB AFTER TAKING BLOOD SAMPLE FROM CHEMO PORT. LEAKAGE PRESENT FROM INJECTION PORT. BLOOD AT THE END OF INJECTION PORT AFTER CHECKING THE PATENCY AND WAS UNABLE TO FLUSH BACK AS THE BLOOD RETAINED. PATIENT WAS NOT IMPACTED OR SERIOUS INJURY, HOWEVER THERE WAS A DELAY WITH THE START OF CHEMOTHERAPY. ONE HUBER NEEDLE WAS USED , SAFE STEP HUBER NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311165 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, AS PER DR, WHEN SHE OPENED THE NON CORING NEEDLE FOR ACCESSING THE PORT AS SOON AS SHE ATTACHED THE SYRINGE THE NEEDLE STARTED LEAKING. SHE NEVER APPLIED ANY PRESSURE OR FLUSHED THE NEEDLE BUT THE FLOW CAME THROUGH THE NON CORING NEEDLE. WHEN THEY PHYSICALLY CHECKED THE NON CORING NEEDLE AT THE HOSPITAL WITH THE SAME DR THE NEEDLE WAS NOT LEAKING, BUT THE DR FORCEFULLY TOLD THEM WHEN SHE TRIED AT THE PATIENT BEDSIDE IT WAS LEAKING AND WAS NOT READY TO ACCEPT THAT THEIR IS NO LEAKAGE IN THE PRODUCT. INCIDENT OCCURRED BEFORE USAGE, REQUIRED A NEW UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545440 ↗
• MalfunctionOct 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SAFESTEP NON CORING NEEDLE TIP WAS NOT FINE. WHEN HCP USE THE SAFESTEP NEEDLE TO ACCES THE PORT PATIENT FEELS THE PAIN DURING THE PRICK AS WELL AS REMOVAL OF THE NEEDLE AND REPORTED IT TO HCP. THEREFORE HCP WHEN REMOVING THE NEEDLE AND PATIENT COMPLAINED ABOUT THE PAIN. PATIENT BODY FLUID AND BLOOD EXPOSURE TO THE SAMPLE. PATIENT GOT STUCK TWICE FOR PORT ACCESS. THEY USED THE FRESH UNIT OF THE PRODUCT. ON 10/17/2023, THE RETUNED NEEDLE EXHIBITED A BEND IN THE NEEDLE TIP.

  Patient problems: Pain

  MAUDE report 18021439 ↗
• MalfunctionSep 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CAME AND THEY OBSERVED THE LEAKAGE FROM HUB AT Y SITE OF SAFESTEP (THE JUNCTION WHERE THE NFC HUB IS THERE. ADDITIONAL INFORMATION RECEIVED 9/6/2023: IT WAS REPORTED THIS OCCURRED BETWEEN (B)(6). THERE WERE NO AIR BUBBLES ASSOCIATED WITH THE LEAK, JUST FLUID DROPS FROM THE BREAKAGE POINT WHEN THE STAFF TRIED TO FLUSH. THE SURFACE IS CLEANED AND THE SAFESTEP WAS REPLACED WITH A NEW ONE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782310 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE IVAD ACCESSED WITH HUBER NEEDLE, FLUSHED WITH NS, WRITER DREW BACK AND BRISK BLOOD RETURN NOTED AND THEN RE-FLUSHED. AFTER IVAD FLUSHED COMPLAINANT NOTICED SANG COLORED SALINE LEAKING FROM SECOND HUB (HUB CLOSEST TO PATIENT). APPEARED TO BE LEAKING FROM IN BETWEEN BLUE AND WHITE COMPONENTS OF THE PUSH HUB. COMPLAINANT DE-ACCESSED THIS HUBER NEEDLE FOR INCREASED INFECTION RISK AND RISK OF CHEMOTHERAPY SPILL. THERE WAS NO APPARENT HARM. IT WAS INCONVENIENT FOR THE PATIENT. ADDITIONAL INFORMATION (B)(6) 2023: THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO SERIOUS HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596553 ↗
• MalfunctionMay 18, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM COULD NOT BE ACTIVATED. NO IMPACT ON PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955221 ↗
• MalfunctionMay 9, 2023Misassembled; Detachment of Device or Device Component; Misassembled; Detachment of Device or Device Component

  IT WAS REPORTED, "DE-ACCESSED IVAD AS PER STANDARD PROCEDURE. AS I WITHDREW THE HUBER NEEDLE FROM THE PATIENTS IVAD IT BECAME IMMEDIATELY DETACHED FROM THE BASE. THERE WAS NO CATCHING OR ATTEMPT FOR THE BASE TO HOLD THE NEEDLE IN THE SAFETY POSITION. THE NEEDLE BECAME FREE WITHOUT ANY RESISTANCE. I DID NOT POKE MYSELF NOR WAS THE PATIENT POKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897227 ↗
• MalfunctionApr 14, 2023Crack; Crack

  IT WAS REPORTED "PORT ACCESS NEEDLE CRACKED HORIZONTALLY AT THE LUER LOCK OF THE PREATTACHED CONNECTOR." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746798 ↗
• MalfunctionFeb 14, 2023Defective Component; Defective Component

  IT WAS REPORTED THE NEEDLE IS ALSO WOBBLY AND NOT STABLE WITHIN THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376243 ↗