Portex 24-1302-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019517075342), received between Dec 2, 2024 and Aug 26, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461571 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE SNAPPED DURING REMOVAL AT ABOUT 1CM FROM THE BLUE TIP. A COMPUTED TOMOGRAPHY (CT) SCAN OF PATIENT¿S LUMBAR SPINE DIDN'T SHOW THE RETAINED SECTION. A MAGNETIC RESONANCE IMAGING (MRI) COULD NOT BE UNDERTAKEN AS THE PATIENT HAD JUST HAD A KNEE PROSTHESIS IMPLANTED. PATIENT WAS ASYMPTOMATIC UNTIL THE MOMENT THE ANESTHETIST REPORTED THE ISSUE. THE PATIENT WAS AN 81Y OLD, 112KG, MALE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22495369 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS IN LABOR AND UPON REMOVAL OF EPIDURAL CATHETER, THE TIP OF THE EPIDURAL CATHETER WAS MISSING. PER REPORTER, THE CATHETER WAS REMOVED WITH EASE, AND THERE WAS NO DIFFICULTY OR TENSION. THE PATIENT UNDERWENT AN MRI AND NO FOREIGN BODY WAS REPORTED. A CT SCAN WAS ALSO PERFORMED, AND NO FOREIGN BODY WAS IDENTIFIED. THE PATIENT WAS DISCHARGED. REPORTER STATED THAT UPON ADDITIONAL REVIEW OF THE MRI AND CT RESULTS, THERE WAS THEN AN ADDENDUM WHICH STATED THAT THE TIP OF THE EPIDURAL CATHETER WAS PRESENT ON THE MRI. THE CUSTOMER STATED THAT THIS ADDENDUM HAD NOT BEEN COMMUNICATED WITH THE ANESTHETIC OR OBSTETRIC TEAMS AND THAT THE CLINICAL TEAMS WERE UNAWARE OF THIS CHANGE IN FINDINGS.

  Patient problems: Insufficient Information

  MAUDE report 22061143 ↗
• MalfunctionFeb 13, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT TWO SYRINGES HAVE ENTRAINED AIR VIA THE PLUNGER RATHER THAN ASPIRATING THE SALINE. THE PLUNGER ELEMENT WAS TOO LOOSE INSIDE THE BARREL WHEN PULLED BACK. THE USER EXPLAINED THAT PROBABLY IT WOULDN¿T HAVE BEEN AN ISSUE IF USING SALINE FOR LOSS OF RESISTANCE, BUT IF USING AIR, THEN THE AIR MIGHT HAVE EXPELLED ¿VIS¿ THE PLUNGER ELEMENT, GIVING A FALSE END POINT FOR LOSS OF RESISTANCE, AS ONE CAN¿T CHECK IF THE SYRINGE IS WORKING BEFOREHAND. THERE WAS PATIENT INVOLVEMENT, BUT NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379081 ↗
• MalfunctionDec 31, 2024Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE OPERATOR OF THE DEVICE TO FEED THE CATHETER THROUGH TOUEY EVEN AFTER THEY TRIED TO ROTATE IT. BOTH TOUEY AND CATHETER WERE EVENTUALLY REMOVED BUT IT APPEARED TO BE BROKEN. THERE WERE FOUR PATIENTS INVOLVED IN THIS EVENT. UNKNOWN PATIENT HARM WAS REPORTED DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048371 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT WHILE SITING THE EPIDURAL FOR A WOMAN IN LABOR, THE HEALTHCARE PROFESSIONAL WAS UNABLE TO FEED THE CATHETER THROUGH THE TOUEY. TRIED TO ROTATE 180 DEGREES BUT STILL UNABLE TO FEED CATHETER. TOUEY AND CATHETER WERE REMOVED, BUT WHILE PULLING BACK, A SNAP WAS FELT. TIP OF CATHETER HAD BEEN SHEARED OFF. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035947 ↗
• MalfunctionDec 2, 2024Complete Blockage; Material Rupture; Complete Blockage; Material Rupture

  IT WAS REPORTED THAT EPIDURAL FILTER SPLIT AT THE SEAM DURING TEST DOSE INJECTION AT LOW PRESSURE, FLUID DID NOT GO DOWN THE CATHETER. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827979 ↗

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-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• 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-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