Port Access Needle LH-0029Recalls & reported problems

Summary

The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 00801741066160), received between Apr 23, 2018 and Sep 24, 2026 — classified as 4 injuries, 375 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (144 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 379 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Failure to Infuse

  It was reported that health professional performed the puncture but encountered resistance during the injection of the solution. health professional replaced the SurePlug, but the problem persisted. This appears to be a needle malfunction. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883626 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211080 ↗
• MalfunctionJul 6, 2026Failure to Infuse

  IT WAS REPORTED HEALTH PROFESSIONAL TRIED TO PASS WATER ON A SALINE DIET, BUT THERE IS NO WAY. THERE WAS NO PATIENT CONTACT. (B)(6) 2026 IT WAS FOUND DURING AN INVESTIGATION AN OCCLUSION WAS OBSERVED AT THE NEEDLE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719847 ↗
• MalfunctionJun 18, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SAFESTEP NEEDLE IS BENT. THERE WAS NO PATIENT CONTACT. ON 06/02/2026: IT WAS FOUND DURING INVESTIGATION THE NEEDLE SHAFT WAS BENT AT ITS BASE AND THE SAFETY MECHANISM COULD NOT BE ACTIVATED DUE TO THIS BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550017 ↗
• MalfunctionJun 17, 2026Material Twisted/Bent; Activation Problem

  IT WAS REPORTED AFTER ADMINISTERING THE MEDICATION TO THE PATIENT, HEALTH PROFESSIONAL ATTEMPTED TO REMOVE THE NEEDLE, BUT THE SAFETY MECHANISM DID NOT ENGAGE. THERE WAS NO REPORTED PATIENT INJURY. NO NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533360 ↗
• MalfunctionMay 13, 2026Failure to Infuse

  IT WAS REPORTED THAT WHEN DISPENSING LIQUID WITH THE SYRINGE, THE PLUNGER DOES NOT MOVE FORWARD, PREVENTING DISPENSING. THE SAME ISSUE OCCURS EVEN AFTER EXCHANGING THE SYRINGE. WHEN HEALTH PROFESSIONAL EXCHANGED THE SYRINGE FOR ANOTHER NEEDLE, IT WORKED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160293 ↗
• MalfunctionMay 5, 2026Misassembled; Component Missing

  IT WAS REPORTED THAT WHEN HEALTH PROFESSIONAL OPENED THE PACKAGING AND PRIMED THE SYRINGE, HEALTH PROFESSIONAL CHECKED THE NEEDLE TIP AND NOTICED THAT THE NEEDLE COVER, WHICH SHOULD HAVE BEEN THERE, WAS MISSING. TWO NURSES WHO WERE PRESENT SEARCHED FOR IT AND CHECKED, BUT THEY CONFIRMED THAT IT WAS INDEED MISSING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087495 ↗
• MalfunctionApr 27, 2026Activation Problem

  IT WAS REPORTED THAT THE NEEDLE-STICK PREVENTION MECHANISM CAME LOOSE WHILE THE PATIENT WAS USING IT. THERE WAS NO REPORTED PATIENT INJURY OR NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000948 ↗
• MalfunctionApr 6, 2026Material Twisted/Bent

  IT WAS REPORTED DURING IV FLUID ADMINISTRATION VIA A CENTRAL VENOUS CATHETER, AN OCCLUSION ALARM SOUNDED, AND UPON REMOVING THE NEEDLE, IT WAS FOUND TO BE BENT. THERE WAS NO REPORTED PATIENT INJURY. 03/26/2026: IT WAS FOUND DURING AN INVESTIGATION THE NEEDLE WAS OBSERVED TO BE BENT AT THE PROXIMAL END OF THE NEEDLE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795048 ↗
• MalfunctionApr 6, 2026Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT HEALTH PROFESSIONAL TRIED TO REMOVE THE NEEDLE, BUT THE SAFETY MECHANISM DIDN'T ENGAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794114 ↗
• MalfunctionMar 31, 2026Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT UPON WITHDRAWAL AFTER USING SAFESTEP, HEALTH PROFESSIONAL FELT A SNAG, AND THE NEEDLE COULD NOT BE RETRACTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749956 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CONTACTED THE TREATMENT AREA STATING THEY FELT WETNESS ON THEIR NIGHTGOWN, AND THE TEGADERM DRESSING WAS DAMP. THE PATIENT WAS CONCERNED THAT CHEMOTHERAPY MAY HAVE BEEN LEAKING FROM THE LINE. SHE WAS INSTRUCTED TO COME IN FOR ASSESSMENT AND WAS ADVISED TO REMOVE THE NIGHTGOWN AND PLACE IT IN A BIOHAZARD BAG, WHICH SHE DID. UPON ARRIVAL, THE PATIENT¿S PORT AND THE ONGOING FLUOROURACIL INFUSION WERE ASSESSED. THE TEGADERM DRESSING WAS WET TO THE TOUCH, AND A SMALL AMOUNT OF LIQUID WAS VISIBLE UNDER THE DRESSING. THE PORT FLUSHED EASILY WITH GOOD BLOOD RETURN. THE CAP ATTACHMENT AT THE PORT WAS INSPECTED, AND THE CONNECTION WAS FOUND TO BE NOT COMPLETELY TIGHTENED. STAFF TIGHTENED THE CAP AND ALL RELATED ATTACHMENTS, REMOVED THE WET TEGADERM, CLEANSED THE SKIN, AND APPLIED A NEW TEGADERM DRESSING. THE POSITION OF THE WHITE SENSOR WAS ADJUSTED FROM BETWEEN THE BREASTS TO THE SIDE OF ONE BREAST. STAFF NOTED THE POSSIBILITY THAT MOVEMENT OF BREAST TISSUE MAY HAVE LOOSENED THE CAP, THOUGH THIS WAS NOT CONFIRMED. THE PORT NEEDLE REMAINED IN PLACE. THE PATIENT LEFT AND WAS INSTRUCTED TO RETURN LATER THE SAME DAY ONCE THE INFUSION BOTTLE WAS EMPTY. WHEN THE P

  Patient problems: Chemical Exposure

  MAUDE report 24749953 ↗
• MalfunctionMar 31, 2026Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT AFTER ADMINISTERING THE MEDICATION, WHEN HEALTH PROFESSIONAL TRIED TO FLUSH THE LINE AND REMOVE THE NEEDLE, THE SAFETY MECHANISM IS NOT FUNCTIONING PROPERLY AND FAILED TO ENGAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749705 ↗
• MalfunctionMar 30, 2026Misassembled

  IT WAS REPORTED THAT THERE WAS NO NEEDLE COVER WHEN OPENING THE PACKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716194 ↗
• MalfunctionMar 26, 2026Misassembled

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGE TO USE THE PRODUCT, THE NEEDLE PRICKS THE DOCTOR¿S HAND BECAUSE THERE IS NO PROTECTIVE CAP ON THE NEEDLE. THE PROTECTIVE CAP WAS MISSING FROM THE START. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24702407 ↗
• MalfunctionMar 23, 2026Material Twisted/Bent; Activation Problem

  ADDITIONAL INFORMATION 04/10/2026: CUSTOMER CLARIFIED THAT THE REPORT THAT THE DEVICE "COULD NOT BE STORED" MEANS THAT WHEN ATTEMPTING TO ACTIVATE THE SAFETY MECHANISM, THE NEEDLE DID NOT LIFT AND COULD NOT BE PROPERLY LOCKED. THERE WAS NO NEEDLE STICK INJURY. THE BEND IS BELIEVED TO BE IN THE SHAFT OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663896 ↗
• MalfunctionMar 18, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT HUBER NEEDLE IS DISCONNECTING FROM THE EXTENSION SET. TUBING IS ULTIMATELY BREAKING. NO ADVERSE EVENTS OR INJURY OCCURRED TO PATIENT OR WORKER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635350 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED HEALTH PROFESSIONAL NOTICED A LEAK FROM THE TUBING DURING ADMINISTRATION. BLOOD WAS PRESENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489451 ↗
• MalfunctionFeb 2, 2026Activation Problem

  IT WAS REPORTED THAT DURING NEEDLE REMOVAL, THE FIXATION PLATE DID NOT DESCEND FULLY AND BECAME STUCK MIDWAY, REMAINING IN THAT POSITION. AFTER NEEDLE REMOVAL, HEALTH PROFESSIONAL CHECKED THE FIXATION PLATE'S MOBILITY, BUT IT STOPPED HALFWAY (ABOUT HALFWAY) AND FELT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235432 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak; Activation Problem

  IT WAS REPORTED THAT THE DISC CRACKED AND LEAKED. NO FURTHER DETAILS PROVIDED. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184435 ↗
• MalfunctionJan 6, 2026Activation Problem

  IT WAS REPORTED THAT THE HUBER NEEDLE FROM THE SAFESTEP NEEDLE GUARD WOULD NOT LOCK AND ONLY REACH HALF OF THE LENGTH OF THE NEEDLE. THE NEEDLE WAS ABLE TO BE REMOVED FROM THE PATIENT SAFELY AND THE HUBER NEEDLE WAS INTACT. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975768 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT USE OF SAFE STEP WAS DISCONTINUED AFTER DETECTING CHEMICAL LEAKAGE FROM THE AREA . NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957587 ↗
• MalfunctionDec 17, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT WHEN WRITER WAS DOING AN IVAD ACCESS. NO DIFFICULTY WITH SAME. CHECKED FOR BLOOD RETURN AND THERE WAS NONE. UNABLE TO FLUSH SAME. WRITER ATTEMPTED TO REPOSITION NEEDLE DEVICE BUT REALIZED THAT IT SEEMED TO BE BENT AS IT WAS VERY DIFFICULT TO PULL BACK ON SAME. AT THIS POINT, AS THE DEVICE APPEARED TO BE QUESTIONABLE, WRITER REMOVED SAME TO DISCOVER THAT THE NEEDLE WAS INDEED BENT AT ALMOST A 90-DEGREE ANGLE SIDEWAYS. WRITER DID NOT ATTEMPT TO FLUSH AGAIN PRIOR TO REMOVAL. NO UNEXPECTED OR PROLONGED CARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831261 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, LEAKING FROM THE HOUSING. ADDITIONAL INFORMATION 12-DEC-2025: THE PICC IS STILL WITH THE PATIENT, THE REMOVED DATE IS NOT SURE YET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828907 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, LEAKING FROM THE HOUSING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790911 ↗