Portex 4905Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20351688009033), received between Feb 16, 2018 and Feb 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PORTEX PLASTIC 'LOSS OF RESISTANCE' SYRINGE LEAKED WHEN PRESSURE WAS APPLIED. THE EPIDURAL COULD NOT BE POSITIONED CORRECTLY, THEREFORE PAIN CONTROL WAS NOT PROVIDED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 7278257 ↗

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-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-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-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
• 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-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-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-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

…and 16 more.