Portex 4042ERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20351688039184), received between Nov 27, 2024 and Dec 17, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN DRAWING AN ARTERIAL BLOOD GAS, BLOOD LEAKED OUT OF THE SYRINGE BENEATH THE PLUNGER AND WAS BROKEN. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828876 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879178 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877779 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6), 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877705 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877681 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877663 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877554 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN JULY 21 AND 25, 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877531 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877113 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877085 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SITE TOOK A SAMPLE IN THE INTENSIVE CARE UNIT (ICU) AND SENT IT TO THE BLOOD BANK VIA THE PNEUMATIC TUBE. WHEN IT ARRIVED AT THE BLOOD BANK, THE CAP HAD COME LOOSE, AND THE SAMPLE WAS LOST. THE SITE HAD TO RE-COLLECT THE PATIENT'S SAMPLE. THIS HAPPENED ON DIFFERENT DAYS FROM IN BETWEEN ON (B)(6) 2025. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877025 ↗
• MalfunctionNov 27, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DEVICE "GRIPS IMMEDIATELY" AND DIDN'T RETAIN THE BLOOD, RESULTING IN BLOCKAGE DURING THE ASPIRATION. IT WAS STATED THAT THERE SEEMED TO BE A LACK OF HEPARIN INSIDE THE SYRINGES, OR AT LEAST AN INSUFFICIENT QUANTITY, MEANING THAT THE BLOOD IMMEDIATELY COAGULATED IN THE SYRINGE, MAKING DIFFICULT TO ANALYZE THE SAMPLE AND HAVING TO MANEUVER IT SEVERAL TIMES. THE EVENT TOOK PLACE IN THE EMERGENCY ROOM. THE INCIDENT WAS FIXED BY REPEATING THE MANEUVER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798269 ↗

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-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-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-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-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-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-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-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

…and 16 more.