Portex 4558PGRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20351688081169), received between Jan 4, 2018 and Mar 31, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734115 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734113 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734112 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734079 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734076 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734066 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734055 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734052 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734043 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734040 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734030 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734029 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734026 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734009 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734004 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733998 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733989 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733986 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733971 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE THREAD OF THE SYRINGE IS DEFORMED: IT IS OVAL INSTEAD OF ROUND, WHICH MAKES IT DIFFICULT TO REMOVE THE NEEDLE POST-COLLECTION. THE FILTER IS NOT WATERPROOF, IT IS LEAKING, AND BLOOD IS FLOWING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733967 ↗
• InjuryJan 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER HAVING PERFORMED A BLOOD GAS ANALYSIS USING A PRO-VENT PLUS, 3CC LL SYRINGE, 23G X 1IN NDLE, FILTER+ EDGE, THE NURSE FIXED THE FILTER PRO DEVICE AND THEN SLOWLY PUSHED THE PLUNGER TO RELEASE THE AIR BUBBLES. ALL OF THE BLOOD CAME OUT OF THE SYRINGE DIRTYING THE NURSES IN THE FACE AND EYES. THE STAFF WERE EXPOSED TO CONTAMINATED BLOOD. NO OTHER INFORMATION WAS PROVIDED TO INDICATE ANY OTHER ADVERSE EVENTS OR MEDICAL INTERVENTIONS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7164042 ↗

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-1715-2020 · Jan 7, 2020 · Terminated
  Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
• Z-1716-2020 · Jan 7, 2020 · Terminated
  Portex ProVent Arterial Blood Sampling Kit 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-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-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-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
• 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-1183-2014 · Nov 22, 2013 · Terminated
  4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, si
• 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-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

…and 16 more.