Portex 24-1301-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019517073935), received between Apr 25, 2024 and Dec 23, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K965017); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Complete Blockage; Material Twisted/Bent; Complete Blockage; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE TRYING TO ASSURE EPIDURAL SPACE, THERE WAS A LOSS OF RESISTANCE TO SALINE, AS IT COULDN¿T PASS THROUGH THE CATHETER. AFTER REMOVING THE CATHETER, THEY CONFIRMED THE TUOHY POSITION USING THE LOR SALINE SYRINGE, INJECTING MORE SALINE TO OPEN UP THE SPACE AND TRIED AGAIN WITH A NEW CATHETER. THEY EVENTUALLY MANAGED TO PASS IT, CONTINUOUSLY INJECTING SALINE VIA THE CATHETER, BUT WITH QUITE A BIT OF DIFFICULTY. WHEN THEY REMOVED THE TUOHY NEEDLE, THE TIP WAS BENT OVER, WHICH WOULD EXPLAIN THE RESISTANCE AND CATCHING ISSUES. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL STAFF. THE OUTCOME OF THE EVENT IS THAT THE EPIDURAL WORKED WELL AND PROVIDED EFFECTIVE PAIN RELIEF FOR THE WOMAN DURING LABOR. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882858 ↗
• MalfunctionNov 20, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AFTER ARRIVAL FROM THE OPERATING ROOM, IT WAS OBSERVED THAT THE TUBING BEFORE THE FILTER WAS KINKED, CAUSING AN OCCLUSION ALARM WHEN ATTEMPTING TO ADMINISTER A BOLUS. TWO DOCTORS WERE CALLED IN TO HELP CUT AWAY THE DAMAGED TUBING AND CHECK THAT IT WAS THEN FUNCTIONING PROPERLY. THE PATIENT WAS NOT RECEIVING ADEQUATE PAIN RELIEF. IT WAS ALSO STATED THAT THE NEW TUBING FOR THE NRFIT SYSTEM IS THICK AND STIFF. IT HAS HAPPENED SEVERAL TIMES THAT, DESPITE STANDARD TAPING, THE TUBING BECAME KINKED, AND THE MEDICATION DELIVERY STOPPED. THERE WAS PATIENT INVOLVEMENT. SAMPLE PHOTOS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605788 ↗
• MalfunctionAug 20, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE COULD NOT ADMINISTER TO THE PATIENT, AND THE ANESTHESIOLOGIST COULD NOT GET IT TO WORK ON THE PATIENT. THE EVENT OCCURRED WHEN THE DOCTOR WAS ABOUT TO ADMINISTER THE EPIDURAL DURING USE WITH THE PATIENT. ALL ANESTHESIOLOGISTS HAD MORE OR LESS ISSUES PLACING AN EPIDURAL WITH THE CONNECTION DEPENDING ON THE PATIENT. AN OLDER VERSION OF THE DEVICE HAD TO BE USED INSTEAD. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849477 ↗
• MalfunctionApr 29, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LOSS OF RESISTANCE SYRINGE MALFUNCTIONED WHEN THE ANESTHETIST WANTED TO DRAW SODIUM CHLORIDE INTO IT. COULDN¿T GET ANY LIQUID UP IN THE SYRINGE AT ALL. THE DOCTOR TRIED A FEW TIMES, BUT IN THE END, THEY HAD TO CHANGE IT. THE EVENT OCCURRED DURING AN EPIDURAL, AND THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930305 ↗
• MalfunctionMar 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE EPIDURAL CATHETER WAS FOUND TO BE DISCONNECTED FROM THE FILTER COULD NOT BE RECONNECTED BECAUSE OF INFECTION RISK. EPIDURAL CATHETER REMOVED FROM PATIENT AND OFFERED PATIENT CONTROLLED INTRAVENOUS ANALGESIA. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724044 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS GREAT DIFFICULTY IN INSERTING THE EDA CATHETER EVEN THOUGH THE NEEDLE WAS CORRECTLY POSITIONED IN THE BACK. THE ANESTHESIOLOGIST HAD TO STAB THE PATIENT¿S BACK SEVERAL TIMES AND WITH SEVERAL EDA CATHETER SETS BEFORE THE PATIENT COULD GET A FUNCTIONING EDA. THIS HAD HAPPENED ON SEVERAL OCCASIONS WITH DIFFERENT DOCTORS AND PATIENTS. THE EVENT DATE IS UNKNOWN. THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION COULD BE PROVIDED ABOUT THE OTHER LOT NUMBERS USED AS THE PRODUCTS WERE THROWN AWAY. THERE WAS NO HUMAN HARM. THE PATIENT WAS STUNG SEVERAL TIMES AND THIS LED TO A LONGER PERIOD UNTIL THE PATIENT RECEIVED THE MEDICINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863984 ↗
• MalfunctionNov 4, 2024Disconnection; Failure to Deliver; Disconnection; Failure to Deliver

  IT WAS REPORTED THAT AFTER SWITCHING TO THE NRFIT VERSION OF EPIDURAL MINIPACK SYSTEM, A DISCONNECTION OCCURRED BETWEEN THE YELLOW CLIP HOLDING THE CATHETER AND THE BACTERIAL FILTER WITHIN THE FIRST TWO WEEKS OF USE. IT APPEARS THAT THE SCREW CONNECTION BETWEEN THE YELLOW CLIP HOLDING THE CATHETER AND THE BACTERIAL FILTER IN THE NRFIT VERSION IS NOT SUFFICIENTLY SECURE. THE EVENT TOOK PLACE IN THE MATERNITY UNIT, DIRECTLY AFFECTING THE PATIENT, RESULTING IN FAILED PAIN RELIEF DURING LABOR. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599694 ↗
• MalfunctionOct 1, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT WAS NOTICEABLY DIFFICULT TO INSERT THE EPIDURAL CATHETER THROUGH THE TOUHY NEEDLE ON THE NEW NRFIT SETS. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344894 ↗
• MalfunctionSep 18, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE SNAPPED AND BENT WHILE IN USE. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WAS NO PATIENT HARM, BUT THE EPIDURAL WAS ABANDONED, AND A SPINAL WAS USED INSTEAD. THE PATIENT REQUIRED A MORPHINE PCA BY THE TIME THE PROCEDURE HAD FINISHED DUE TO THE SPINAL ANESTHESIA WEARING OFF. THERE WAS NO MEDICAL INTERVENTION NEEDED. THE OUTCOME OF THE EVENT IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246163 ↗
• InjuryApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE CONNECTOR ON THE DEVICE COMPLETELY SNAPPED OFF. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K965017. One submission often covers many models, so check the product and lot details in each record.

• Z-1101-2026 · Dec 19, 2025 · Open, Classified
  Portex Spinal Tray, Item No. A3729-24 A3595
• Z-0211-2007 · Oct 27, 2006 · Terminated
  Portex Continuous Epidural tray Ref 4948-17
• Z-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• Z-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• Z-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• Z-0166-04 · Oct 10, 2003 · Terminated
  Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20