Portex 24-1300-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 15019517075335), received between May 1, 2024 and Mar 2, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Break

  IT WAS REPORTED THAT THE EPIDURAL CATHETER BROKE OFF WHEN REMOVING CATHETER AND 4CM WAS LEFT IN PATIENT. CATHETER REMAINS IN PATIENT, AS SURGERY TO REMOVE DECIDED NOT TO BE IN HER BEST INTEREST. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24483006 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE EPIDURAL CATHETER WAS INSERTED IN A PATIENT AND SECURED USING THE LOCKIT FIXATION DEVICE. ON THE FOLLOWING DAY, THE PATIENT WAS NOTED TO HAVE A MAJOR EPIDURAL LEAK, RESULTING IN INEFFECTIVE ANALGESIA. THE CATHETER WAS SUBSEQUENTLY REMOVED AND WAS FOUND TO BE FRACTURED AT THE POINT WHERE IT HAD PASSED THROUGH THE LOCKIT DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OTHER THAN INADEQUATE ANALGESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366248 ↗
• MalfunctionSep 12, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE YELLOW LOCK CAUSES THE CATHETER TO BECOME COMPLETELY BLOCKED WHEN SECURED IN PLACE, RESULTING IN A RE-SITE OF THE LABOR EPIDURAL. REPORTER STATED THAT, ON OPENING THE EPIDURAL PACK, THE YELLOW END COMES OUT OF THE PACK ONLY HALF OPENED, AND WHEN THE USER THREADS IT INTO THE DEVICE WHEN IT IS STILL IN THE HALF-OPENED POSITION, CLOSES THE CLAMP AND TRIES TO FLUSH, THEY EXPERIENCED A BLOCKED CATHETER. REPORTER STATED THAT, IF THE YELLOW END BIT IS FULLY OPENED (WINGS EXTENDED) BEFORE THE CATHETER IS THREADED, THEN WHEN CLOSED IT MORE OFTEN THAN NOT FLUSHES CORRECTLY. AS THE PATIENT HAD TO BE RE-SITED, THERE WAS A DELAY IN ACHIEVING THE REQUIRED PAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037659 ↗
• MalfunctionSep 10, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED NUMEROUS FAULTY EPIDURAL CATHETER LOCKS WITHIN THEIR CURRENT BATCH. APPROXIMATELY 1 IN 3 OF THEM THE YELLOW LOCK WILL THEN CAUSE THE CATHETER TO BE COMPLETELY BLOCKED WHEN SECURED IN PLACE. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015035 ↗
• MalfunctionMay 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE EPIDURAL CATHETER SNAPPED, LEAVING 1CM OF CATHETER INSIDE PATIENT. THE REPORTER STATED A NEUROSURGICAL OPINION WAS SOUGHT, WHICH ADVISED THAT NO IMAGING OR SURGICAL INTERVENTION WAS NECESSARY. HOWEVER, AFTER A CONSULTANT ANESTHETIST REVIEW, AN MRI WAS CONDUCTED AS A BASELINE INTERVENTION, WHICH DID NOT REVEAL ANY FOREIGN BODY. UPON THE MOST RECENT REVIEW OF THE PATIENT¿S NOTES, IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030499 ↗
• MalfunctionFeb 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE CATHETER AND FILTER DISCONNECTED WHEN IT WAS BEING ATTACHED. WHEN THE USER CONNECTED THE CATHETER TO THE FILTER, SHE SCREWED IT ON. WHEN SHE DID THAT, THE YELLOW TOP MADE A POP SOUND, AND IT THEN VERY EASILY DISCONNECTED FROM THE FILTER. THE ANESTHETIST HAD 3 CATHETERS WITH THE SAME ISSUE ALL FROM BATCH#: 4461203. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333073 ↗
• MalfunctionDec 12, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN SETTING UP THE CAP, THE YELLOW END BECAME DISCONNECTED. IT WAS NOT ATTACHED TO THE PATIENT, BUT IT RESULTED IN ANOTHER KIT BEING OPENED. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914053 ↗
• MalfunctionDec 12, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN SETTING UP THE CAP, THE YELLOW END BECAME DISCONNECTED. IT WAS NOT ATTACHED TO THE PATIENT, BUT IT RESULTED IN ANOTHER KIT BEING OPENED. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913625 ↗
• MalfunctionDec 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHILE PREPARING THE CATHETER/CONNECTOR/FILTER, ONCE CONNECTED, IT WOULDN'T FLUSH THE SALINE TO PRIME. THE CONNECTOR/FILTER WAS REPLACED WITH THE SAME FROM ANOTHER KIT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868708 ↗
• MalfunctionNov 27, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THERE WAS HIGH RESISTANCE IN THE FLOW OF THE MEDICATION, AND A SUBSEQUENT PCA (PATIENT-CONTROLLED ANALGESIA) DOSE VIA THE EPIDURAL PUMP GAVE A "DOWNSTREAM OCCLUSION" ALARM. THE FILTER/CONNECTORS WERE CHANGED TO FRESH ONES FROM ANOTHER KIT AND THE ISSUE WAS RESOLVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797847 ↗
• 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 20599738 ↗
• 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 20246408 ↗
• MalfunctionAug 22, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED DUE TO A BROKEN EPIDURAL FILTER RESULTING IN EARLY CATHETER REMOVAL. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025221 ↗
• MalfunctionJun 13, 2024Complete Blockage; Failure to Advance; Complete Blockage; Failure to Advance

  IT WAS REPORTED THAT THE ANESTHETIST WAS UNABLE TO FEED CATHETER THROUGH THE END OF THE NEEDLE INTO THE EPIDURAL SPACE WHEN IN SITU, DUE TO BEING MET WITH RESISTANCE WHEN THE CATHETER REACHES THE END OF THE TOUHY NEEDLE AND HAD TO REDO THE PROCEDURE UNTIL SUCCESSFUL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533904 ↗
• MalfunctionMay 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SLIGHTEST OVERTIGHTENING OF THE FILTER LEADS TO A DISCONNECTION AND THE NEED TO OPEN A NEW PACK. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WERE MULTIPLE DEVICES AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221861 ↗

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-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• Z-0244-06 · Nov 17, 2005 · Terminated
  4904 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