Portex 24-1000-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517054651), received between May 12, 2020 and Jan 21, 2026 — classified as 3 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K172410); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Partial Blockage

  IT WAS STATED THAT NRFIT SCIATIC AND FEMORAL NERVE CATHETERS WERE INSERTED SEPARATELY ON (B)(6) 2025. BOTH WERE CONNECTED TO SEPARATE 5 ML PER HOUR PUMPS. THE FEMORAL NERVE CATHETER WAS COMPLETELY DRAINED BY ON (B)(6) 2025, BUT THE SCIATIC NERVE CATHETER WAS ABOUT HALF DRAINED. MANUAL BOLUS ADMINISTRATION OF THE FEMORAL CATHETER VIA THE EXISTING FILTER AND CONNECTOR WAS NORMAL. EXTREMELY HIGH PRESSURE WAS ENCOUNTERED WHEN ATTEMPTING TO BOLUS THE SCIATIC NERVE CATHETER. NEW FILTER INSTALLED AND CONNECTED, FLUSHED WITHOUT PROBLEM, BUT AFTER CONNECTING IT TO THE CATHETER, THE SAME PROBLEM OCCURRED: VERY HIGH PRESSURE AND NOT FLUSHING. ANOTHER ATTEMPT WITH A NEW CONNECTOR-FILTER FROM AN EPIDURAL PACK WITH THE SAME PROBLEM. THE PATIENT'S CATHETER APPEARED TO BE UNDAMAGED AND PATENT UPON VISUAL INSPECTION. WHEN THE NEW FILTER-CONNECTOR COMBINATIONS WERE THEN INITIALLY TESTED ON THE NEW EPIDURAL CATHETER, THEY FLUSHED THE CATHETER WITHOUT PROBLEM. HOWEVER, WHEN UNLOCKING AND LOCKING THE CONNECTOR, THEY COULD NO LONGER FLUSH DESPITE NO OBVIOUS DAMAGE BEING VISIBLE. THERE WAS PATIENT INVOLVEMENT. THE INCIDENT HAS BEEN REPORTED TO THE REGULATORY AGENCY. NCA REFERENCE: (B)(4) AICXML. ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132990 ↗
• MalfunctionNov 10, 2025Partial Blockage; Partial Blockage

  IT WAS STATED THAT NRFIT SCIATIC AND FEMORAL NERVE CATHETERS WERE INSERTED SEPARATELY ON (B)(6) 2025. BOTH WERE CONNECTED TO SEPARATE 5 ML PER HOUR PUMPS. THE FEMORAL NERVE CATHETER WAS COMPLETELY DRAINED BY(B)(6) 2025, BUT THE SCIATIC NERVE CATHETER WAS ABOUT HALF DRAINED. MANUAL BOLUS ADMINISTRATION OF THE FEMORAL CATHETER VIA THE EXISTING FILTER AND CONNECTOR WAS NORMAL. EXTREMELY HIGH PRESSURE WAS ENCOUNTERED WHEN ATTEMPTING TO BOLUS THE SCIATIC NERVE CATHETER. NEW FILTER INSTALLED AND CONNECTED, FLUSHED WITHOUT PROBLEM, BUT AFTER CONNECTING IT TO THE CATHETER, THE SAME PROBLEM OCCURRED: VERY HIGH PRESSURE AND NOT FLUSHING. ANOTHER ATTEMPT WITH A NEW CONNECTOR-FILTER FROM AN EPIDURAL PACK WITH THE SAME PROBLEM. THE PATIENT'S CATHETER APPEARED TO BE UNDAMAGED AND PATENT UPON VISUAL INSPECTION. WHEN THE NEW FILTER-CONNECTOR COMBINATIONS WERE THEN INITIALLY TESTED ON THE NEW EPIDURAL CATHETER, THEY FLUSHED THE CATHETER WITHOUT PROBLEM. HOWEVER, WHEN UNLOCKING AND LOCKING THE CONNECTOR, THEY COULD NO LONGER FLUSH DESPITE NO OBVIOUS DAMAGE BEING VISIBLE. THERE WAS PATIENT INVOLVEMENT. THE INCIDENT HAS BEEN REPORTED TO THE REGULATORY AGENCY. NCA REFERENCE 2025 003 009 501 016 AND MHR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512680 ↗
• MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER CONNECTED THE PRODUCT (A FLAT FILTER) TO A THIRD PARTY'S PRODUCT AND STARTED ADMINISTRATION OF MEDICAL FLUID. ABOUT 7 HOURS LATER, MEDICAL FLUID LEAKED FROM THE FILTER. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10048951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172410. One submission often covers many models, so check the product and lot details in each record.

• Z-0152-2022 · Dec 8, 2020 · Terminated
  smiths medical portex Loss of Resistance Device, REF 100/398/000
• Z-1820-2020 · Feb 28, 2020 · Terminated
  Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid p