Port Access Needle LH-0031Recalls & reported problems

Summary

The FDA's MAUDE database contains 350 adverse event reports that list this exact device (DI 00801741066207), received between Apr 24, 2018 and Jul 1, 2026 — classified as 10 injuries, 340 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (140 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 350 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE CANNOT FULLY RETRACT AFTER USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679110 ↗
• MalfunctionJun 24, 2026Activation Problem

  IT WAS REPORTED BY MEDWATCH WHEN DE-ACCESSING PORT NEEDLE FROM PATIENT AND IT WOULDN'T PULL BACK INTO THE SAFETY LOCK, AND THEN WHEN THE NURSE TRIED TO PULL IT STRAIGHT OUT IT WAS DIFFICULT, HAD TO HOLD HIS PORT SECURE AND PULL OUT SLOWLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608404 ↗
• MalfunctionMay 21, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE CANNOT BE RETRACTED. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250170 ↗
• MalfunctionMay 21, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE CANNOT BE RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250167 ↗
• MalfunctionApr 21, 2026Misassembled

  IT WAS REPORTED AFTER OPENING SAFESTEP HUBER NEEDLE, RN NOTICED THAT NEEDLE COVER WAS NOT PRESENT. RN AND TEAM LOOKED TO SEE IF COVER COULD HAVE FALLEN OFF IN PACKAGING OR FLOOR - NO COVER FOUND. NO NEEDLESTICK INJURY OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945575 ↗
• MalfunctionApr 21, 2026Activation Problem

  IT WAS REPORTED SAFETY WOULD NOT ACTIVATE; I WATCHED HER TRY MULTIPLE TIMES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945123 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED, ONE INSTANCE BLOOD WAS OBSERVED DRIPPING FROM THE SAME DISTAL END OF THE PIGTAIL DURING A LAB DRAW. BLOOD INFUSED. THE PORTS WERE RE-ACCESSED WITH NEW NEEDLES FROM OTHER LOTS, AND THE PROBLEM WAS NOT REPRODUCED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640664 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED, DRUG PRECIPITATE WAS OBSERVED AROUND THE DISTAL END OF THE PIGTAIL TUBING ON THE NEEDLE FOR MOST INSTANCES; 5-FLUOROURACIL INFUSING. PATIENTS DID NOT RECEIVE THEIR FULL PRESCRIBED DOSE OF CHEMOTHERAPY, BUT THE AMOUNT LEAKED IS UNMEASURABLE, SO PATIENTS ARE UNDERDOSED ON CRITICAL MEDICATIONS, LOCALIZED SKIN IRRITATION DUE TO HAZARDOUS DRUG EXPOSURE. THE PORTS WERE RE-ACCESSED WITH NEW NEEDLES FROM OTHER LOTS, AND THE PROBLEM WAS NOT REPRODUCED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24640159 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED, DRUG PRECIPITATE WAS OBSERVED AROUND THE DISTAL END OF THE PIGTAIL TUBING ON THE NEEDLE FOR MOST INSTANCES; ETOPOSIDE INFUSING. PATIENTS DID NOT RECEIVE THEIR FULL PRESCRIBED DOSE OF CHEMOTHERAPY, BUT THE AMOUNT LEAKED IS UNMEASURABLE, SO PATIENTS ARE UNDERDOSED ON CRITICAL MEDICATIONS, LOCALIZED SKIN IRRITATION DUE TO HAZARDOUS DRUG EXPOSURE. THE PORTS WERE RE-ACCESSED WITH NEW NEEDLES FROM OTHER LOTS, AND THE PROBLEM WAS NOT REPRODUCED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24640136 ↗
• MalfunctionMar 18, 2026Activation Problem

  IT WAS REPORTED THAT WHEN REMOVING THE SAFESTEP AFTER USE, HEALTH PROFESSIONAL FELT A SNAGGING SENSATION ON THE NEEDLE, PREVENTING PROPER NEEDLE RETRACTION. NO NEEDLE STICK INJURY AND NO SERIOUS HARM OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631939 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER USING, WHEN PULL OUT THE NEEDLE, IT DISCONNECTED FROM THE HOUSING. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630165 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE SAFESTEP, THE ROOT LUER LOCK WAS PROPERLY CONNECTED TO THE THREE-WAY VALVE OF THE INFUSION SET, BUT BLOOD LEAKED FROM THE LUER LOCK SECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530434 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  IT WAS REPORTED SEVEN CASES OF IV TUBING LEAKING FROM THE PORTS AND IN SEVERAL INSTANCES, HAZARDOUS MEDICATIONS HAVE BEEN EXPOSED TO BOTH PATIENTS AND STAFF DUE TO THE LEAKAGE. NO ADVERSE EVENTS OR INJURIES HAVE BEEN REPORTED. THIS REPORT ADDRESSES ALL SEVEN CASES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 24511643 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO INSTANCES OF HUBER NEEDLE SAFESTEP LEAKING AT THE LUER LOCK CONNECTION TO THE HUBER NEEDLE. HAZARDOUS MEDICATIONS HAVE BEEN EXPOSED TO BOTH PATIENTS AND STAFF DUE TO THE LEAKAGE. THIS REPORT ADDRESSED BOTH DEVICES.

  Patient problems: Chemical Exposure

  MAUDE report 24495941 ↗
• MalfunctionMar 2, 2026Activation Problem

  IT WAS REPORTED THAT AFTER ADMINISTERING LH-0031 VIA INJECTION, THE NEEDLE TIP FAILED TO RETRACT UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY. NO NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484262 ↗
• MalfunctionFeb 10, 2026Activation Problem

  IT WAS REPORTED THAT AFTER ADMINISTERING LH-0031 VIA INJECTION, THE NEEDLE TIP FAILED TO RETRACT UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307965 ↗
• MalfunctionFeb 9, 2026Activation Problem

  IT WAS REPORTED, THE NEEDLE CANNOT RETRACT COMPLETELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291491 ↗
• MalfunctionJan 29, 2026Activation Problem

  IT WAS REPORTED THAT AFTER ADMINISTERING FLUIDS WITH THE SAFESTEP DEVICE, I FLUSHED IT WITH SALINE AND ATTEMPTED TO ACTIVATE THE SAFESTEP'S SAFETY MECHANISM. HOWEVER, THE NEEDLE ONLY RETRACTED HALFWAY BEFORE STOPPING, PREVENTING THE NEEDLE TIP FROM BEING FULLY RETRACTED. WITH THE NEEDLE TIP STILL PROTRUDING, I REMOVED THE SAFESTEP FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208352 ↗
• MalfunctionJan 15, 2026Activation Problem

  IT WAS REPORTED THAT HUBER NEEDLE IS NOT SAFETY WHEN DE-ACCESSED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088391 ↗
• MalfunctionJan 7, 2026Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PORT NEEDLE'S SAFETY FEATURE DID NOT ENGAGE/RETRACT WHEN NURSE DE-ACCESSED PATIENT. NEEDLE STILL EXPOSED. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994321 ↗
• InjuryDec 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED "I WAS REMOVING THE HUBER FROM A PATIENT. THE SAFETY MECHANISM FAILED AND RESULTED IN A NEEDLE STICK INJURY. THE ACTUAL SAFETY COVER CAME COMPLETELY DETACHED FROM THE HUBER NEEDLE ITSELF, SO INSTEAD OF HOLDING IT ALL IN ONE PIECE, I HAD THE HUBER IN ONE HAND AND SAFETY COVER IN THE OTHER. THIS ONE BLED QUITE A LOT INITIALLY. I WAS REQUIRED TO BE EVALUATED AT OUR OCCUPATIONAL HEALTH CLINIC. ALL LABS ARE WITHIN NORMAL LIMITS AT THIS TIME. I HAVE A FOLLOW UP APPOINTMENT IN 2 WEEKS. IF I REMEMBER CORRECTLY, LABS HAVE TO BE DRAWN THEN AND AGAIN IN 6 MONTHS.".

  Patient problems: Needle Stick/Puncture

  MAUDE report 23853938 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER RN ACCESSED PORT, DRAWING INITIAL/WASTE/BLOOD RETURN SHE NOTED BUBBLES IN SYRINGE. SHE FLUSHED AND NOTICED LIQUID (NON CHEMO) DRIPPING FROM LUER AREA AND TUBING. SHE CHANGED THE CAP AND EXPERIENCED THE SAME ISSUE. SHE DE-ACCESSED AND GOT NEW SET UP. PATIENT HAD TO BE ACCESSED TWICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585902 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER INFUSIONS WERE COMPLETED, THE RN NOTICED A WET SPOT ON THE PATIENT'S SHIRT WHERE THE IV TUBING CONNECTED TO THE PORT TUBING. THIS WAS UNHOOKED AND THE NEEDLELESS CONNECTER WAS REPLACED. UPON FLUSHING, THE RN NOTICED THE PORT TUBING CONTINUING TO LEAK. THERE SEEMED TO BE A CRACK SOMEWHERE WITHIN THE TUBING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 23584408 ↗
• MalfunctionNov 12, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THERE WERE THREE OCCURRENCES OF THE SAFETY MECHANISM NOT ENGAGING ON THE NEEDLE SET UPON DE-ACCESSING THE IVAD IMPLANTED PORT. THIS REPORT ADDRESSES ALL THREE DEVICES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534414 ↗
• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY MEDWATCH RN WAS DOING A PORT FLUSH ON A PATIENT. WHEN PORT FLUSH COMPLETE, RN WAS ATTEMPTED TO ENGAGE THE SAFETY ON THE NEEDLE AND IT WAS NOT ENGAGING. THE NEEDLE WAS CAREFULLY REMOVED FROM THE PATIENT AND RN AGAIN ATTEMPTED TO ENGAGE THE SAFETY WHILE NO LONGER IN PATIENT AND WAS STILL UNABLE TO ENGAGE. NEEDLE WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438366 ↗