Portex G1469JRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00351688060238), received between Jul 9, 2024 and May 14, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DIGIT (1) WAS MARKED ON THE SYRINGE OF THE LINE-DRAW MAIN BODY WITH "MAGIC [MARKER]. THERE IS NO AFFECTED ITEM NOW, AND DIGIT (3) WAS MARKED THERE PER THE INFORMATION GAINED". THE EVENT OCCURRED BEFORE OPENING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018880 ↗
• MalfunctionApr 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "BLOOD WAS LEAKING FROM THE FILTER SECTION OF THE FILTER PRO". THE EVENT OCCURRED IN (B)(6) 2024 OR SO AT THE HOSPITAL. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762434 ↗
• MalfunctionMar 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAP DID NOT CLOSE, AND IT CAME OFF QUICKLY. ACCORDING TO THE USER FACILITY, THERE WERE NO INFECTIOUS DISEASE REPORTED DUE TO THE RESULT OF THE EVENT. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622081 ↗
• MalfunctionMar 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAP DID NOT CLOSE, AND IT CAME OFF QUICKLY. ACCORDING TO THE USER FACILITY, THERE WERE NO INFECTIOUS DISEASE REPORTED DUE TO THE RESULT OF THE EVENT. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621843 ↗
• MalfunctionMar 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAP DID NOT CLOSE, AND IT CAME OFF QUICKLY. ACCORDING TO THE USER FACILITY, THERE WERE NO INFECTIOUS DISEASE REPORTED DUE TO THE RESULT OF THE EVENT. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621762 ↗
• MalfunctionMar 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAP DID NOT CLOSE. IT SEEMED TO COME OFF WITHOUT ANY RESISTANCE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544023 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN BLOOD GAS WAS DRAWN, THERE WAS BLOOD LEAKING OUT OF THE DEVICE. ANOTHER PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT DEVICE WAS USED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASES OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376026 ↗
• MalfunctionFeb 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CUSTOMER PERFORMED A BLOOD GAS MEASUREMENT, THEY COULDN'T PULL IT TIGHT ENOUGH AND BLOOD LEAKED OUT INTO THE CONNECTION. WHEN THE CUSTOMER CHECKED THE CONNECTION WITH THE SAME BLOOD GAS KIT AGAIN AND TOOK A SAMPLE, THE SITUATION WAS THE SAME. WHEN CUSTOMER SWITCHED TO ANOTHER KIT AND TOOK IT, CUSTOMER WAS ABLE TO COLLECT IT WITHOUT ANY PROBLEMS. WHEN CUSTOMER TOOK THE KIT OUT, THERE WAS A CRACK. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355229 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED TO THE TIP OF THE FILTER PRO. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED DURING PATIENT USE, AND THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798118 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "BLOOD EXPOSURE." THE EVENT OCCURRED IN (B)(6) 2024. THE SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE EVENT OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558674 ↗
• MalfunctionJul 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME CHEMICAL WAS COMING OUT OF THE SYRINGE. NO INFECTION, STERILIZATION, OR DISINFECTION OCCURRED. THE REPORTED ISSUE OCCURRED DURING PATIENT USE, AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774664 ↗
• MalfunctionJul 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITH THE DEVICE LEAKAGE OF BLOOD WAS OBSERVED DURING SYRINGE USE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706613 ↗

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-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-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-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-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-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-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-1191-2014 · Nov 22, 2013 · Terminated
  G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles Arterial
• Z-1182-2014 · Nov 22, 2013 · Terminated
  4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devi
• Z-1192-2014 · Nov 22, 2013 · Terminated
  G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle Arterial Blood Sampling Line Draw S
• 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-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

…and 16 more.