Portex 4043ERecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20351688039191), received between Nov 14, 2022 and Jan 13, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE VACUTAINER WAS SCREWED ONTO THE PERIPHERAL VENOUS CATHETER TO TAKE SAMPLES. WHEN THE BLOOD GAS SYRINGE WAS PUSHED INTO THE VACUTAINER, OVER THE NEEDLE OR MEMBRANE, THE VACUTAINERS STARTED LEAKING BACKWARDS, NAMELY AT THE CONNECTION TO THE PVC. LIKEWISE, THE BLOOD GAS SYRINGE LEAKED BLOOD THROUGH THE LOWER MEMBRANE OR FILTER, WHICH LEAD TO BLOOD SPILLAGE. THERE WAS PATIENT INVOLVEMENT. ATTACHED TO THE COMPLAINT THERE IS A PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053080 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN DRAWING AN ARTERIAL BLOOD GAS, BLOOD LEAKS OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882893 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE WAS LIKELY PUNCTURED PRIOR TO INSERTION AT THE ARTERIAL PORT. BLOOD SPURTED OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681174 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER CAP FOR THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. THE EVENT DATE IS 20-JAN-2025. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204037 ↗
• MalfunctionJun 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FILTER CAP OF THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. NO PATIENTS WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198361 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 3 SYRINGES WERE TESTED AND 2 OF THEM LEAKED IN THE CAP, WHEREAS ONE OF THEM LEAKED BLOOD ON THE SIDES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186959 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT BLOOD GAS SYRINGES WERE LEAKING BLOOD FROM THE CAPS. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023233 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD WAS LEAKING OUT OF THE AIR VENT FILTER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023082 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE AIR VENT FILTER WAS FILLING WITH BLOOD AND LEAKING. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965021 ↗
• MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN SAMPLING WITH A BLOOD GAS SYRINGE THERE WAS LEAKAGE IN THE FILTER. THERE WAS UNKNOWN PATIENT HARM AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21669834 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT BLOOD GAS SYRINGES WERE LEAKING BLOOD FROM THE CAPS. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638838 ↗
• MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD WAS LEAKING OUT OF THE AIR VENT FILTER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560252 ↗
• MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED TWO BLOOD GAS SYRINGES WITH LEAKING CAPS. THERE WERE UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510526 ↗
• MalfunctionFeb 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE LEAKED IN THE CAP WHEN THEY ARE FILLED, AND BLOOD WAS LEAKING. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463372 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER CAP FOR THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. THE EVENT DATE IS (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359425 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER CAP FOR THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. THE EVENT DATE IS (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359061 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER CAP FOR THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. THE EVENT DATE IS (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358821 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER CAP FOR THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. THE EVENT DATE IS 20-JAN-2025. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358750 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SEVERAL BLOOD GAS SYRINGES WERE LEAKING/ALLOWING BLOOD TO SEEP THROUGH THE ENTIRE BARREL WHEN AIR WAS BEING EXPELLED FROM THE SYRINGE TO ANALYZE THE SAMPLE. THIS THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. UPDATE: GCM RECEIVED AN EMAIL ON 20-JAN-2025 FROM MS. (B)(6) STATING THAT NO PATIENTS HAVE BEEN HARMED, AS THIS OCCURRED AFTER THE SAMPLE HAD BEEN TAKEN FROM THE ARTERIAL NEEDLE. HOWEVER, THERE WAS A RISK OF BLOOD SPILLAGE. THIS HAD HAPPENED ON MULTIPLE OCCASIONS AND DATES, BUT THE FIRST OCCURRENCE WAS ON (B)(6) 2025. (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356234 ↗
• MalfunctionFeb 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FILTER CAP OF THE BLOOD GAS SYRINGES LEAKS BLOOD AFTER SAMPLING. NO PATIENTS WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304264 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER DISCOVERED THAT THE FILTER CAP OF THE BLOOD GAS SYRINGES LEAKED BLOOD AFTER SAMPLING. NO PATIENTS WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300170 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING SAMPLING IN THE DIALYSIS MACHINE, THE TIP OF THE ACID SYRINGE BROKE OFF AND GOT STUCK IN THE MEMBRANE, THUS CREATING A LARGE LEAK THAT WAS MANUALLY STOPPED BY HAND. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506635 ↗
• InjuryNov 14, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT IN AN EVENT WHERE THE PATIENT PRESENTED WITH CARDIAC ARREST, AN ATRIAL BLOOD GAS WAS TO BE TAKEN BUT COULD NOT BE CARRIED OUT BECAUSE THE NEW BLOOD GAS SYRINGE IS NOT THE SAME VACUUM AS THE OLD ONE AND THERE WAS NOT ENOUGH BLOOD IN THE SYRINGE. THE CUSTOMER ENDED UP HAVING THE ANESTHETIST PUT IN AN ARTERIAL NEEDLE AND TOOK BLOOD GAS FROM THERE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792630 ↗

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-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-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-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-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-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-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-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

…and 16 more.