Portex 4598P-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20351688040333), received between Oct 22, 2024 and Feb 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

31 other recalls cover devices cleared under the same FDA submission (K952516); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A STRONG FLASH OF BLOOD, FILLED HUB OR NEEDLE THEN NO BLOOD FLOWED INTO SYRINGE DESPITE STRONG PULSES PALPATED. CARE WAS DELAYED. ATTEMPTS WERE ON FEMORAL ARTERY, AND THEY HAD TO STOP THE BLEEDING. THERE WAS PATIENT INVOLVED AND NO HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24433659 ↗
• MalfunctionNov 26, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY NEEDLE SAFETY SYSTEM, A NEEDLE FELL OFF AND POKED THE RT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658146 ↗
• MalfunctionMay 24, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE CAP FAILED TO SECURE THE NEEDLE AND WHEN REMOVING THE CAP, THE NEEDLE RELEASED AND PUNCTURED THE NURSE'S FINGER WHICH CAUSED THE NURSE TO SUFFER A NEEDLE STICK INJURY FROM A CONTAMINATED BLOOD SAMPLE FROM A NEWBORN CORD BLOOD. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT DEATH.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22081932 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS OBSERVED WHILE THE DEVICE WAS USED ON PATIENT. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965043 ↗
• MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE FROM FILTER PRO. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763625 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLOOD DRAW COULDN'T BE USED BECAUSE IT WAS LEAKING THROUGH THE FILTER. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025978 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE CAP WAS LEAKING BLOOD FROM THE TOP. THE EVENT OCCURRED AT THE HOSPITAL AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724080 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTED CAPS WERE LEAKING THE BLOOD SAMPLE OUT WHEN THEY WERE GETTING THE AIR OUT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509424 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952516. One submission often covers many models, so check the product and lot details in each record.

• Z-1100-2026 · Dec 19, 2025 · Open, Classified
  Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
• Z-0141-2024 · Sep 6, 2023 · Open, Classified
  Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
• Z-1716-2020 · Jan 7, 2020 · Terminated
  Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
• Z-1715-2020 · Jan 7, 2020 · Terminated
  Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
• Z-0843-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 405
• Z-0842-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-
• Z-1028-2015 · Dec 17, 2014 · Terminated
  Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling
• Z-1184-2014 · Nov 22, 2013 · Terminated
  4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Li
• Z-1188-2014 · Nov 22, 2013 · Terminated
  G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are
• Z-1189-2014 · Nov 22, 2013 · Terminated
  G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per
• Z-1190-2014 · Nov 22, 2013 · Terminated
  G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line
• Z-1186-2014 · Nov 22, 2013 · Terminated
  4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1187-2014 · Nov 22, 2013 · Terminated
  4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1180-2014 · Nov 22, 2013 · Terminated
  4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device Arterial B
• Z-1181-2014 · Nov 22, 2013 · Terminated
  4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devi

…and 16 more.