Port Access Needle LH-0035Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00801741066283), received between Jun 29, 2018 and Apr 22, 2026 — classified as 2 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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-2671-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Misassembled

  IT WAS REPORTED THAT WHEN HEALTH PROFESSIONAL OPENED THE PACKAGE, THE NEEDLE WAS NOT SHEATHED FROM THE START, AND THE TIP WAS EXPOSED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961286 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE TUBING IS BREAKING ABOVE THE HUB. ADDITIONAL INFORMATION RECEIVED: SHE IS A 1 YEAR OLD THAT NEEDED RE-ACCESSED AFTER EACH NEEDLE BREAK. SHE EXPERIENCED SOME BLOOD LOSS (SOME MORE THAN OTHERS) DEPENDING ON WHEN THE BREAK WAS CAUGHT. SHE HAD DELAYS AND INTERRUPTIONS OF CHEMO AND FLUIDS. SOME BREAKDOWNS OF SKIN FROM MULTIPLE DRESSING CHANGES. HER LINE ALSO NEEDED TO HAVE TPA INSTILLED AT LEAST ONCE DUE TO CLOTTING OFF. SHE IS CURRENTLY AT HOME RECEIVING BLINATUMOMAB AND WE HAD TO START A PICC LINE BECAUSE WE COULDN'T TRUST THAT HER NEEDLE WOULDN'T BREAK AT HOME DURING THE MONTH-LONG INFUSION (NEEDLE CHANGES EVERY 7 DAYS). IF THE DRUG IS DELAYED DUE TO DISCONNECTION OR BREAKAGE OF LINE FOR MORE THAN 4 HOURS THE PATIENT WOULD HAVE TO BE READMITTED FOR CLOSER MONITORING ON RESTART OF THE DRUG. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24781847 ↗
• MalfunctionJan 7, 2026Activation Problem

  IT WAS REPORTED AFTER ADMINISTERING THE NUTRIENT SOLUTION VIA THE SAFESTEP, WHEN ATTEMPTING TO FLUSH WITH SALINE TO ACTIVATE THE SAFESTEP'S SAFETY FEATURE, THE NEEDLE STOPPED MIDWAY, AND THE SAFETY FEATURE DID NOT ACTIVATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995653 ↗
• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT EXTENSION SET BROKE ON A POWERLOC MAX. NO FURTHER INFORMATION AVAILABLE OR PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946496 ↗
• MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BROWN DEBRIS-LIKE PARTICLES WERE FOUND MIXED IN WITH THE INDIVIDUALLY WRAPPED ITEMS NEAR THE NEEDLE TIP, END POINT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853433 ↗
• MalfunctionDec 12, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT WHEN REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791146 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE SAFESTEP WAS INSERTED INTO THE PORT, A SYRINGE CONTAINING SALINE WAS CONNECTED, AND BLOOD WAS ADMINISTERED AND BACKFLOW WAS CHECKED, BLOOD LEAKED INTO THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731998 ↗
• MalfunctionJun 27, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT OPERATE. NEEDLE DOES NOT RETRACT. THERE WAS NOT A NEEDLE STICK INJURY OR HARM TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345752 ↗
• MalfunctionJun 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS NO DISCOMFORT DURING THE PUNCTURE, AND IT WAS PERFORMED SMOOTHLY. THE PATIENT WENT HOME WITH THE PUNCTURE STILL IN PLACE. WHEN HE RETURNED TO THE HOSPITAL TO HAVE IT REMOVED, THE SAFETY DEVICE DID NOT ACTIVATE. THE NEEDLE WAS NOT RETRACTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292406 ↗
• MalfunctionJun 17, 2025Misassembled; Misassembled

  IT WAS REPORTED WHEN SETTING UP TO ACCESS PATIENT'S IVAD CUSTOMER HAD STERILE GLOVES ON AND WAS OPENING THE CARDBOARD FLAP UP ON THE SAFESTEP HUBER NEEDLE SET. THEY IMMEDIATELY FELT A STAB AND NOTED THAT THE NEEDLE SET DID NOT HAVE A CAP ON, RESULTING IN A STERILE NEEDLESTICK INJURY TO THEIR LEFT THUMB, UNDER THE NAIL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22248451 ↗
• MalfunctionJun 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PLASTIC FRAGMENTS FOUND IN THE PACKAGING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204060 ↗
• MalfunctionJun 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT AFTER REMOVAL (SAFETY MECHANISM DID NOT ACTIVATE). IT WAS REPORTED THAT THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128976 ↗
• InjuryApr 30, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A NURSE WHO DE-ACCESSED A PORT THAT WAS ACCESSED BY A SAFE STEP PORT NEEDLE LAST WEEK AND A NEEDLE INJURY OCCURRED. THE REF: (B)(4) LOT: ASJSGC106. THE NURSE DID INDICATE SHE EXPERIENCED A NEEDLE STICK INJURY, I BELIEVE IT WAS FOR A CHEMOTHERAPY INFUSION AND CARE PARTNERS HAS A PROTOCOL TO TAKE AFTER A NSI OCCURS. HOWEVER, I DO NOT HAVE DETAILS OF WHAT SPECIFICALLY HAPPENED AFTERWARD. THE NURSE INDICATED THAT THE SAFETY MECHANISM WAS ENGAGED AND THE NEEDLE CAME OUT AFTER THE SAFETY WAS ACTIVATED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 21935039 ↗
• MalfunctionMar 19, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "PATIENT AT HOME FOR A HOME PARENTAL NUTRITION NOTIFIED OUR UNIT THAT THE NEEDLE BROKE INTO PIECES WHILST TRYING TO DE ACCESS HER PORT (WE HAVE BEEN TOLD BY THE PATIENT THAT HER MUM ACCESSES AND DE ACCESSES THE PORT). SHE REMOVED THE BROKEN NEEDLE HERSELF AND WAS THEN ADVISED TO ATTEND EMERGENCY TO HAVE THE PORT ASSESSED AND BE SCANNED BY INTERVENTIONAL RADIOLOGY. SHE DID AND WAS CLEARED AND DISCHARGED HOME WITH NIL ILL OUTCOME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649614 ↗
• MalfunctionMar 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PLASTIC FRAGMENTS FOUND IN THE PACKAGING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548035 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT'S MOM CALLED OUT FOR HELP FROM ROOM SAYING "BLOOD ALL OVER PATIENT'S LEG FROM HIS TUBE." UPON ENTERING ROOM, PATIENT IN HIGHCHAIR, NOTED WITH SIZABLE WET, BLOODY STAIN ON PAJAMA PANTS. IVF NOTED TO BE LEAKING FROM SPLIT IN LINE AT THE HUB/CAP END FROM THE PAC NEEDLE TUBING. IVF IMMEDIATELY STOPPED, LINE CLAMPED. MDS ALSO IN TO ASSESS. PAC NEEDLE REMOVED AND PATIENT IMMEDIATELY RE-ACCESSED WITHOUT ISSUE. PATIENT WAS BLEEDING, SO MINOR HARM WAS CAUSED TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21318088 ↗
• MalfunctionJan 14, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN THE NEEDLE WAS REMOVED FROM THE CV PORT, THE SAFETY MECHANISM DID NOT FUNCTION PROPERLY, LEAVING THE TIP OF THE NEEDLE EXPOSED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151334 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SAFETY INCIDENT THAT OCCURRED WITH SAFESTEP HUBER NEEDLE SET WITHOUT Y-INJECTION SITE, 22G X 0.5". RN WAS FLUSHING PORT A CATH LINE AND NOTED NORMAL SALINE SPRAYING FROM LINE. UPON INSPECTION OF LINE TUBING, IT WAS NOTED THE LINE WAS BROKEN. A NEW KIT WAS OPENED AND USED. THE PATIENTS WERE NOT HARMED, NOR DID THEY EXPERIENCE DISCOMFORT, OR PAIN. INCREASED MONITORING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864999 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SAFETY INCIDENT THAT OCCURRED WITH SAFESTEP HUBER NEEDLE SET WITHOUT Y-INJECTION SITE. RN WAS FLUSHING PORT A CATH LINE AND NOTED NORMAL SALINE SPRAYING FROM LINE. UPON INSPECTION OF LINE TUBING, IT WAS NOTED THE LINE WAS BROKEN. A NEW KIT WAS OPENED AND USED. THE PATIENTS WERE NOT HARMED, NOR DID THEY EXPERIENCE DISCOMFORT, OR PAIN. INCREASED MONITORING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864885 ↗
• MalfunctionDec 6, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SAFETY INCIDENT THAT OCCURRED WITH SAFESTEP HUBER NEEDLE SET WITHOUT Y-INJECTION SITE. RN WAS FLUSHING PORT A CATH LINE AND NOTED NORMAL SALINE SPRAYING FROM LINE. UPON INSPECTION OF LINE TUBING, IT WAS NOTED THE LINE WAS BROKEN. A NEW KIT WAS OPENED AND USED. THE PATIENTS WERE NOT HARMED, NOR DID THEY EXPERIENCE DISCOMFORT, OR PAIN. INCREASED MONITORING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864601 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS IV FLUID LEAKING FROM THE DISTAL END OF THE SAFESTEP HUBER NEEDLE SET. THE END USER IS NOTING THAT THE PATIENT RECEIVING IV BLINATNUMAB CONTINUOUS VIA PORT A CATH ON CADD VIP SOILS THE PUMP AT HOME. THERE WAS IV FLUID LEAKING FROM THE DISTAL END OF THE SAFESTEP HUBER NEEDLE SET. HAD TO HAVE PORT A CATH REACCESSED WITH NEW SAFESTEP NEEDLE, TREATMENT WAS INTERRUPTED, MISSED 2 HOURS OF DRUG. CHANGE OF TREATMENT BY SECUREMENT OF NEEDLE SET WITH INFUSION VEST. NO REPORTED INJURIES AT THIS TIME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848967 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS IV FLUID LEAKING FROM THE DISTAL END OF THE SAFESTEP HUBER NEEDLE SET. THE END USER IS NOTING THAT THE PATIENT RECEIVING IV BLINATNUMAB CONTINUOUS VIA PORT A CATH ON CADD VIP SOILS THE PUMP AT HOME. THERE WAS IV FLUID LEAKING FROM THE DISTAL END OF THE SAFESTEP HUBER NEEDLE SET. HAD TO HAVE PORT A CATH REACCESSED WITH NEW SAFESTEP NEEDLE. TREATMENT WAS INTERRUPTED, MISSED 2 HOURS OF DRUG, CHANGE OF TREATMENT BY SECUREMENT OF NEEDLE SET WITH INFUSION VEST. NO INJURIES REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848772 ↗
• MalfunctionNov 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT AFTER THE INJECTION WAS COMPLETED, WHEN TRIED TO ACTIVATE THE SAFETY FEATURE TO REMOVE THE NEEDLE, BUT THE SAFETY FEATURE DID NOT WORK. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738160 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKING FROM THE CONNECTION BETWEEN THE MAIN UNIT AND THE TUBE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568878 ↗
• MalfunctionJun 3, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN TRIED TO REMOVE THE NEEDLE, THE BASE DID NOT LOWER AND THE SAFETY MECHANISM DID NOT WORK. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449307 ↗