Portex 4558PERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20351688039108), received between Jun 10, 2024 and Dec 4, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE ARTERIAL BLOOD COLLECTION NEEDLE BECAME BLOCKED, AND NO BLOOD FLOWED OUT. AFTER REMOVING THE NEEDLE AND PUSHING THE PLUNGER, A BLOOD-CLOT-LIKE TISSUE WAS PUSHED OUT FROM THE NEEDLE TIP. THE ARTERIAL BLOOD COLLECTION NEEDLE AND SITE WERE REPLACED, AND BLOOD COLLECTION WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719803 ↗
• MalfunctionMar 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A PLASTIC PRODUCT ABOUT 0.5CM LONG IN THE SYRINGE OF THE ARTERIAL BLOOD COLLECTION DEVICE KIT. THERE WAS NO PATIENT INVOLVEMENT REPORTED, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720834 ↗
• MalfunctionFeb 13, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE SYRINGE IN FRONT OF THE ARTERIAL KIT WAS SEPARATED AND COULD NOT BE USED. THE BLOOD COLLECTION KIT WAS EVENTUALLY REPLACED, AND THE PUNCTURE WAS REDONE. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381337 ↗
• MalfunctionJan 27, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE ARTERIAL BLOOD WAS COLLECTED, IT WAS FOUND THAT BLOOD WAS FLOWING OUT OF THE ARTERIAL BLOOD COLLECTION DEVICE KIT AND THERE WAS A CRACK IN THE ARTERIAL BLOOD COLLECTION DEVICE KIT SYRINGE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241216 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "CEREBRAL INFARCTION." THE PATIENT'S CONDITION WORSENED. THE ARTERIAL BLOOD COLLECTION DEVICE KIT WAS COLLECTED IN THE MOBILE PULSE ACCORDING TO THE DOCTOR'S INSTRUCTIONS, AND THE PACKAGING OF THE ARTERIAL BLOOD COLLECTION DEVICE KIT WAS CHECKED INTACT AND UNDAMAGED. THE PUNCTURE WAS SUCCESSFUL AND IT WAS FOUND THAT THE BLOOD LEAKED FROM THE NEEDLE CONNECTION SPIRAL, AND A VERY SMALL AMOUNT ENTERED THE NEEDLE TUBE. THE ARTERIAL BLOOD COLLECTION DEVICE WAS IMMEDIATELY WITHDRAWN, AND THE ARTERIAL BLOOD COLLECTION DEVICE KIT WAS REPLACED. THE ARTERIAL BLOOD COLLECTION WAS COMPLETED FOR THE PATIENT AT ANOTHER PUNCTURE POINT. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867424 ↗
• MalfunctionNov 14, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT WHEN DRAWING BLOOD GAS, IT WAS FOUND THAT THE NEEDLE WAS IN THE ARTERY, BUT THE BLOOD WAS NOT MOVING. AFTER CHECKING, IT WAS FOUND THAT THE ARTERIAL BLOOD COLLECTION NEEDLE HAD NO NEGATIVE PRESSURE, RESULTING IN BLOCKAGE OF THE ARTERIAL BLOOD COLLECTION NEEDLE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684035 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE HAD BEEN DETACHED FROM THE HUB AND REMAINED IN THE PATIENT. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569597 ↗
• MalfunctionOct 30, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLE COULD NOT BE SEPARATED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567947 ↗
• MalfunctionOct 30, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CLINICAL PERSONNEL COULDN'T PULL OUT THE NEEDLE AFTER DRAWING BLOOD, HE HAD TO USE PLIERS TO TWIST IT OUT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566965 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CAP WAS PUSHED UP AFTER DRAWING BLOOD FOR ARTERIAL BLOOD GAS ANALYSIS, THE BLUE RUBBER STOPPER IN THE SYRINGE MOVED, CAUSING BLOOD TO FLOW OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494909 ↗
• MalfunctionOct 9, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN AN ARTERIAL BLOOD GAS TEST AND UPON OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE WAS SEPARATED FROM THE NEEDLE HANDLE AND THE NEEDLE FELL OFF AND DID NOT MEET THE STERILITY REQUIREMENTS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410358 ↗
• MalfunctionSep 18, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE BLOOD GAS NEEDLE HAD A HAIR LIKE OBJECT ABOUT 1.5CM LONG WAS FOUND IN THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245914 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT BLOOD GAS ANALYSIS WAS PREPARED FOR THE PATIENT. WHEN THE ARTERIAL BLOOD GAS NEEDLE WAS EXAMINED IT WAS NOT FOUND THAT THE NEEDLE WAS NOT TIGHTLY CONNECTED TO THE NEEDLE. THE NEEDLE FELL OFF AND THE ARTERIAL BLOOD COLLECTION KIT WAS IMMEDIATELY REPLACED WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240831 ↗
• MalfunctionSep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE NURSE DREW THE ARTERIAL BLOOD GAS FROM THE PATIENT. WHEN THE CAP WAS PUSHED UP THE BLUE RUBBER PLUG IN THE SYRINGE MOVED, WHICH CAUSED THE BLOOD TO FLOW OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238606 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT THE NIGHT SHIFT NURSE COLLECTED ARTERIAL BLOOD SAMPLES FOR PATIENTS, AND CHECKED THAT THE ARTERIAL BLOOD COLLECTION NEEDLE WAS INTACT BEFORE COLLECTION. WHEN THE NEEDLE WAS UNSCREWED AND REPLACED WITH THE CONNECTOR AFTER COLLECTION, IT WAS FOUND THAT THE NIPPLE OF THE BLOOD COLLECTION DEVICE WAS BROKEN AND COULD NOT BE CLOSELY CONNECTED WITH THE JOINT, AND THE NURSE IMMEDIATELY REDREW THE BLOOD INTO A NEW BLOOD COLLECTOR FOR DELIVERY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497852 ↗

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-1185-2014 · Nov 22, 2013 · Terminated
  4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use device
• 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-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-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-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-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-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

…and 16 more.