Portex G1470JRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00351688060245), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE CAP DID NOT CLOSE, AND IT CAME OFF QUICKLY. ACCORDING TO THE USER FACILITY, THERE WERE NO INFECTIOUS DISEASE REPORTED DUE TO THE RESULT OF THE EVENT. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621823 ↗
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, ClassifiedPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Z-0141-2024 · Sep 6, 2023 · Open, ClassifiedPortex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
- Z-1715-2020 · Jan 7, 2020 · TerminatedPortex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
- Z-1716-2020 · Jan 7, 2020 · TerminatedPortex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
- Z-0842-2019 · Jun 22, 2018 · TerminatedAplicare 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 · TerminatedAplicare 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 · TerminatedPortex 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 · Terminated4043G-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-1181-2014 · Nov 22, 2013 · Terminated4042-2: 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-1191-2014 · Nov 22, 2013 · TerminatedG1777: 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-1187-2014 · Nov 22, 2013 · Terminated4043E: 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-1190-2014 · Nov 22, 2013 · TerminatedG1762: 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-1188-2014 · Nov 22, 2013 · TerminatedG1469J: 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 · TerminatedG1725: 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 · Terminated4042E: 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
…and 16 more.
Other Tubes, vials, systems, serum separators, blood collection devices
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- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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