Portex G1460JRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00351688060146), received between Jan 14, 2021 and Aug 12, 2025 — classified as 35 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. 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE. THIS OCCURRED DURING USE, HOWEVER THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784893 ↗
• MalfunctionJul 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE WAS BROKEN, CAUSING BLOOD TO LEAK OUT. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569740 ↗
• MalfunctionJul 16, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SYRINGE, AND BLOOD LEAKED. THIS OCCURRED DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524276 ↗
• MalfunctionJun 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN STAFF TRIED TO LET THE AIR OUT WITH THE FILTER PRO, THE FILTER PRO FLEW OUT. THE EVENT OCCURRED DURING PATIENT IN USE/DOSE. THERE IS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160037 ↗
• MalfunctionJun 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN STAFF TRIED TO LET THE AIR OUT WITH THE FILTER PRO, THE FILTER PRO FLEW OUT. THE EVENT OCCURRED DURING PATIENT IN USE/DOSE. THERE IS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160016 ↗
• MalfunctionMay 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKAGE FROM THE VENT FILTER WAS FOUND. THE EVENT OCCURRED DURING USE FOR PATIENT. THERE WAS NO ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081929 ↗
• MalfunctionMay 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD AIR THAT GOT IN AND CAUSED A LEAK. THE EVENT OCCURRED DURING USE IN THE END OF MAR-2025. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942521 ↗
• MalfunctionApr 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE IS A HOLE IN THE HUB. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894249 ↗
• MalfunctionMar 13, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE AIR BLEED WAS DIFFERENT FROM USUAL, SO THE USE WAS DISCONTINUED. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594679 ↗
• MalfunctionJan 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "BLOOD LEAKS FROM THE FILTER PRO". THE EVENT OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159293 ↗
• MalfunctionDec 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT "THERE WAS NO VENT FILTER, DUE TO INITIAL FAILURE AND BLOOD WAS EXPOSED". THE EVENT OCCURRED, DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827870 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITH THE DEVICE BLOOD LEAKAGE OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20387602 ↗
• MalfunctionOct 2, 2024Crack; Crack

  IT WAS REPORTED THAT BEFORE USE, THE SYRINGE WAS DISCOVERED TO BE CRACKED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351737 ↗
• MalfunctionOct 2, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE SYRINGE WAS CRACKED, AND BLOOD WAS LEAKING OUT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351553 ↗
• MalfunctionSep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT USE, BLOOD LEAKED, AND THE SYRINGE WAS DAMAGED THIS OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321282 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Incomplete or Missing Packaging; Fluid/Blood Leak; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE SYRINGE WAS MISSING, AND BLOOD LEAKED. THIS OCCURRED UPON/BEFORE OPENING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246794 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE CESAREAN SECTION, WHEN CORD BLOOD WAS COLLECTED, THE UPPER PART OF THE SYRINGE WAS DAMAGED, AND CORD BLOOD GUSHED OUT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182187 ↗
• MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SYRINGE AND BLOOD EXPOSURE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147413 ↗
• MalfunctionAug 27, 2024Crack; Crack

  IT WAS REPORTED THAT THE OUTER TUBE WAS CRACKED. THIS OCCURRED WHILE IN PATIENT USE AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080814 ↗
• MalfunctionAug 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THERE WAS BLOOD LEAKAGE WITH THE DEVICE. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045949 ↗
• MalfunctionAug 22, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE AND BLOOD LEAKED OUT. THIS HAPPENED TWICE IN A ROW. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042902 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THERE WAS BLOOD LEAKAGE WITH THE DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033777 ↗
• MalfunctionAug 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A VISUAL CHECK UPON OPENING THE PACKAGE REVEALED DAMAGE TO THE SIDE OF THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021607 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN SAMPLING BLOOD, IT WAS CONFIRMED THAT BLOOD WAS LEAKING FROM THE TIP OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006071 ↗
• MalfunctionAug 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN WHEN CHECKED BEFORE USE. DEVICE EVALUATION NOTED A LEAKAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967600 ↗

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-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-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-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-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-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-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-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

…and 16 more.