Port Access Needle LH-0037Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741066320), received between Apr 2, 2020 and Aug 11, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT WAS ACCESSED YESTERDAY USING A 0.5-INCH PORT ACCESS DEVICE (OUR CURRENT ONES). WHEN ACCESSED THERE WAS NO BLOOD RETURN AND COULDN¿T FLUSH. NURSING DE-ACCESSED AND TRIED AGAIN THINKING MAYBE IN THE WRONG SPOT (ALTHOUGH THEY WERE PRETTY CONFIDENT IT WAS) AND RE-ACCESSED THE PATIENT. SAME ISSUE WITH NOT BEING ABLE TO FLUSH OR GET BLOOD RETURN. WHEN TRYING TO DE-ACCESS THIS TIME WE WERE NOT ABLE TO GET THE SAFETY TO ENGAGE. I ENDED UP DE-ACCESSING AND FIDDLING WITH UNTIL I COULD GET THE SAFETY TO ENGAGE ONCE IT WAS REMOVED. WHILE TWO EVENTS OCCURRED DURING THE OVERALL INCIDENT (FAILURE TO INFUSE; SAFETY MECHANISM ACTIVATION PROBLEM), THIS REPORT CAPTURES THE REPORTABLE MALFUNCTION OF THE INABILITY TO ENGAGE THE SAFETY MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773175 ↗
• MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A CRACKED LINE LEAKING AT END OF TUBING THAT CONNECTS TO END. OCCURRED IN A PEDS HEM/ONC PATIENT. LINE WAS PROPERLY SECURED. ITEM WAS NOT USED ON A PATIENT. THERE WAS NO HARM OR NEGATIVE OUTCOME EXPERIENCED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763280 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER "THE PATIENT HAD A PORT-A-CATH INSERTED (B)(6) 2024. PORT-A-CATH LEFT ACCESS BY TEAM FOR ON-GOING MANAGEMENT OF SEVERE BLEEDING DISORDER. PATIENT WAS DISCHARGED BY WARD TEAM IN HEMOPHILIA CENTER. ON (B)(6) 2024 WHEN PORT SITE WAS EXAMINED BY HEMOPHILIA TEAM IT WAS FOUND THAT THE EXTENSION HAD SNAPPED. WE HAD TO REMOVE THE NEEDLE, RE-ACCESS WITH A NEW ONE, AND TAKE BLOODS TO TEST FOR INFECTION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761169 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MODEL LH-0037: TUBING CONNECTED TO THE PORT NEEDLE CRACKED. THE CRACK WAS DIRECTLY ABOVE THE HARD PLASTIC PART (ABOVE WHERE YOU CONNECT THE CAP). THE TUBING WAS CLAMPED ABOVE THE CRACK AND THERE WAS NOTHING INFUSING IN THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222887 ↗
• MalfunctionMar 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT CRACK IN LINE. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913860 ↗
• MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT CRACK IN LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387430 ↗
• MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT NURSE ENTERED ROOM AND NOTICED THAT LINE WAS CRACKED AND LEAKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145567 ↗
• MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT NURSE ENTERED ROOM AND NOTICED THAT LINE WAS CRACKED AND LEAKING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145566 ↗
• MalfunctionOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT BLOOD NOTED LEAKING FROM TUBING. CRACK SEEN- NEEDLE REMOVED. THERE WAS NO IV FLUIDS AND/OR MEDICATIONS WERE INFUSE AT THE TIME OF OCCURRENCE. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED 02/10/2023: NONE DAMAGED NOTED THAT CAUSED LEAKAGE. MEDIPORT NEEDLE HAD TO BE CHANGED EARLIER THAN SCHEDULED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17921091 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE RN NOTED BLOOD LEAKING, CONFIRMED THAT CHEMO TUBING WAS SECURE THEN ATTEMPTED TO FLUSH. HUBER SETUP AND NOTED LEAKING WHERE EXTENSION TUBING MEETS LUER ADAPTER. ADDITIONAL INFORMATION RECEIVED 26 SEP 2023 CHEMOTHERAPY WAS INFUSING AT THE TIME THE LEAK WAS NOTED WHERE THE EXTENSION TUBING MEETS THE LUER CONNECTER. YES, TREATMENT WAS INTERRUPTED WHILE THE HUBER NEEDLE WAS CHANGED OUT. THE NEEDLE WAS SECURED WITH A TEGADERM DRESSING.

  Patient problems: Chemical Exposure

  MAUDE report 17894936 ↗
• MalfunctionSep 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT STATES SHE HAS A POWERPORT THAT SHE USES FOR NORMAL SALINE INFUSIONS AND ZOFRAN ADMINISTRATION ONLY. HER PORT STAYS ACCESSED AND THE NEEDLE IS CHANGE EVERY WEEK. PATIENT STATES HER NURSE ACCESSED HER PORT ON (B)(6) 2023 WITH A SAFESTEP NON-CORING NEEDLE. ON (B)(6) 2023, SHE NOTICED BLOOD HAD BACKED UP INTO THE EXTENSION TUBING AND THERE WAS A CRACK WHERE THE TUBING MEETS THE LUER HUB WHERE THEY CONNECTED THE NEEDLELESS CONNECTOR. PATIENT STATES THEY CHANGED THE NON-CORING NEEDLE, AS IT WAS DUE TO BE CHANGED ANYWAYS. CONFIRMED WITH PATIENT THEY LOCK HER PORT WITH HEPARIN AFTER EACH USE WITH THE BD POSIFLUSH HEPARIN 100 UNITS PER ML, 3 ML TOTAL. THEY DO NOT USE ANY ETHANOL LOCKING SOLUTION. THE NEEDLELESS CONNECTOR THEY ARE USING IS THE ICU MEDICAL MICROCLAVE. PATIENT DID STATE THEY CLEAN THE NEEDLELESS CONNECTOR WITH ALCOHOL BEFORE EACH USE, HOWEVER THEY DO NOT TEND TO GET IT ON THE SAFESTEP EXTENSION TUBING. INFORMED PATIENT WE WILL FORWARD THIS TO OUR PRODUCT COMPLAINTS TEAM TO INVESTIGATE. PATIENT DOES HAVE A SAMPLE OF THE PRODUCT THAT HAS CRACKED, SUGGESTED SHE HOLD ONTO THIS TO SEND IN BUT ENGAGE THE SAFETY MECHANISM FOR SAFE HANDLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726394 ↗
• MalfunctionSep 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT STATES SHE HAS A POWERPORT THAT SHE USES FOR NORMAL SALINE INFUSIONS AND ZOFRAN ADMINISTRATION ONLY. HER PORT STAYS ACCESSED AND THE NEEDLE IS CHANGED EVERY WEEK. ON (B)(6) 2023, SHE NOTICED THERE WAS AIR IN THE EXTENSION TUBING THIS TIME DUE TO THE NON-CORING NEEDLE TUBING AGAIN CRACKING WHERE THE TUBING MEETS THE LUER HUB. PATIENT PROVIDED THE PRODUCT CODE LH0037 AND LOT NUMBER ASGUFC010. CONFIRMED WITH PATIENT THEY LOCK HER PORT WITH HEPARIN AFTER EACH USE WITH THE BD POSIFLUSH HEPARIN 100 UNITS PER ML, 3 ML TOTAL. THEY DO NOT USE ANY ETHANOL LOCKING SOLUTION. THE NEEDLELESS CONNECTOR THEY ARE USING IS THE ICU MEDICAL MICROCLAVE. PATIENT DID STATE THEY CLEAN THE NEEDLELESS CONNECTOR WITH ALCOHOL BEFORE EACH USE, HOWEVER THEY DO NOT TEND TO GET IT ON THE SAFESTEP EXTENSION TUBING. INFORMED PATIENT WE WILL FORWARD THIS TO OUR PRODUCT COMPLAINTS TEAM TO INVESTIGATE. PATIENT DOES HAVE A SAMPLE OF THE PRODUCT THAT HAS CRACKED, SUGGESTED SHE HOLD ONTO THIS TO SEND IN BUT ENGAGE THE SAFETY MECHANISM FOR SAFE HANDLING. ADDITIONAL INFORMATION RECEIVED 15 SEPTEMBER 2023: EVENT DID NOT INTERRUPT TREATMENT OR CAUSE A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726352 ↗
• MalfunctionJul 20, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER ¿PATIENT USED THE NEEDLE, IT WORKED OK BUT SHE WAS UNABLE TO ACTIVATE THE SAFETY MECHANISM WHEN SHE REMOVED IT FROM HER CHEST.¿ ADDITIONAL INFORMATION RECEIVED 7-JULY-2023: IT WAS REPORTED BY THE CUSTOMER ¿EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION, DID NOT CAUSE PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME. NO INTERRUPTION IN TREATMENT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358223 ↗
• MalfunctionJun 30, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT REGISTERED NURSE RN FLUSHED PRIOR TO MED ADMINISTRATION AND LEAK NOTED AT CAP/PIGTAIL CONNECTION SITE. PATIENT IS 1 YEAR AND 7 MONTHS OLD, 10.3KG WITH A HISTORY OF B-ALL. RN FLUSHED PRIOR TO MED ADMINISTRATION AND LEAK NOTED AT CAP/PIGTAIL CONNECTION SITE. TEGADERM IV ADVANCED DRESSING WAS OVER THE NEEDLE AND PROXIMAL PORTION OF THE TUBING, NOT THE PLACE WHERE CRACK WAS NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238812 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT RN STARTED INFUSION AND PATIENT'S DAD NOTED BLOOD COMING FROM HUBER SETUP, NOTED CRACKED TUBING BELOW PORT CONNECTION. ADDITIONAL INFO RECEIVED PATIENT IS 1 YEAR AND 7 MONTHS OLD, 10.3KG WITH A HISTORY OF B-ALL. RN STARTED INFUSION AND PATIENT'S DAD NOTED BLOOD COMING FROM HUBER SETUP, NOTED CRACKED TUBING. TEGADERM IV ADVANCED DRESSING WAS OVER THE NEEDLE AND PROXIMAL PORTION OF THE TUBING, NOT THE PLACE WHERE CRACK WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234752 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER ¿PATIENT¿S PARENTS CALLED BEDSIDE RN INTO ROOM BECAUSE THEY NOTED BLOOD COMING FROM HUBER SET. NO CHEMO INFUSED.¿ ADDITIONAL INFORMATION RECEIVED 6/14/2023: IT WAS REPORTED BY THE CUSTOMER ¿HUBER SET WAS IN USE AT THE TIME OF THE BREAK IN THE SYSTEM. PATIENT IS A 1-YEAR OLD AND REQUIRED A NEEDLE CHANGE BEFORE IT WAS ORIGINALLY SCHEDULED AND DELAYED PATIENT¿S IV FLUIDS.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17231370 ↗
• MalfunctionJun 15, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE BREAK WAS DISCOVERED WHEN HANGING BLOOD AND IT WAS LEAKING FROM THE TUBING. YES IT DID CAUSE A DELAY IN TREATMENT AND WAS INFUSING BEFORE. BLOOD WAS INFUSING AT THE TIME IT HAPPENED. WE HAD TO DEACCESS THE PATIENT AND REACCESS HIM WITH A NEW PORT NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140785 ↗
• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED THAT ON A YOUNG PATIENT AT HOME, THE TUBING BROKE OFF AT THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600221 ↗
• MalfunctionFeb 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE INJECTION OF THE ANTIBIOTIC, THERE WAS A VISIBLE BACKFLOW OF BLOOD. THE NEEDLE WAS CHANGED AND THE PATIENT HAD TO BE RE-INJECTED. THE REMOVED NEEDLE TUBING WHICH APPEARED TO BE CUT IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588135 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA (B)(6) MEDICAL DEVICES ONLINE DATABASE: "E0506 - HEMORRHAGE/BLEEDINGF1001 - ABSENCE OF TREATMENTF2301 - ADDITIONAL DEVICE REQUIREDA14 - INFUSION OR FLOW PROBLEMA0404 - CRACKA050401 - FLUID LEAK." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309286 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, "THE NEEDLE HAD BEEN IN PLACE SINCE MONDAY 15 FEB. WHEN GOING THROUGH THE 10AM ANTIBIOTICS ON FEB 19, THE DRESSING AROUND THE VALVE WAS FOUND TO BE WET. THE CONNECTOR WAS NOT UNSCREWED, BUT THE NEEDLE TUBING WAS SEVERED BEFORE THE CONNECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530055 ↗
• MalfunctionDec 4, 2020Backflow; Crack; Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE DISCOVERED THAT THE EXTENSION TUBING HAD BLOOD BACKED UP IN IT. THE NURSE ASSESSED THE HUBER NEEDLE SET AND NOTED THAT IT WAS LEAKING FROM A CRACK LOCATED AT THE POINT WERE THE EXTENSION TUBING MEETS THE FEMALE LUER CONNECTOR END. THE OLD NEEDLE WAS REMOVED AND RETAINED AND THE PATIENT'S IVAD WAS RE-ACCESSED AND THE 28 DAY INFUSION RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10945417 ↗
• MalfunctionDec 4, 2020Crack; Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFUSION HAD BEEN RUNNING FOR 6 DAYS AND THE PATIENT'S MOTHER NOTICED BLOOD ON THE PATIENT'S SHIRT AROUND THE SITE OF THE IVAD. THE PATIENT WAS TAKEN TO THE INPATIENT UNIT WHERE NURSING REMOVED THE OLD NEEDLE AND ACCESSED THE PATIENT WITH A NEW ONE. IT WAS STATED, A NURSE ASSESSING THE OLD NEEDLE SET NOTED THAT IT WAS LEAKING FROM A CRACK LOCATED AT THE POINT WHERE THE EXTENSION TUBING MEETS THE FEMALE LUER CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10944307 ↗
• MalfunctionApr 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE WAS IN THE PATIENT FOR ALMOST 7DAYS AND THE NURSE ENTERED THE ROOM AND NOTICED THAT THE LINE WAS CRACKED AND LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916702 ↗