PortexRecalls & reported problems across all models

We found 409 models of Portex by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 3,479 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2016 and Sep 30, 2026 — classified as 14 deaths, 571 injuries, 2,894 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (739 reports).

5 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Portex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 19, 2025Open, Classified

   Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

   Z-1101-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Dec 19, 2025Open, Classified

   Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

   Z-1100-2026 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

3. Feb 13, 2025Open, Classified

   Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

   Z-1289-2025 · Root cause: Process change control · names 16 of these models · Recall details · FDA record ↗

4. Sep 6, 2023Open, Classified

   The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.

   Z-0141-2024 · Root cause: Process control · Recall details · FDA record ↗

5. Dec 21, 2020Terminated

   Shipping box may contain wrong model.

   Z-0874-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Portex problems

Portex models

409 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Portex 100/199/075

  Tube, tracheal (w/wo connector)
  4 deaths222 reports
• Portex 101/860/080CZ

  Tube, tracheostomy (w/wo connector)
  188 reports
• Portex 100/199/080

  Tube, tracheal (w/wo connector)
  180 reports
• Portex 100/199/070

  Tube, tracheal (w/wo connector)
  163 reports
• Portex 101/860/075CZ

  Tube, tracheostomy (w/wo connector)
  115 reports
• Portex 100/189/080

  Tube, tracheal (w/wo connector)
  104 reports
• Portex 100/133/060

  Tube, tracheal (w/wo connector)
  88 reports
• Portex 100/133/065

  Tube, tracheal (w/wo connector)
  83 reports
• Portex 100/133/070

  Tube, tracheal (w/wo connector)
  67 reports
• Portex 100/189/075

  Tube, tracheal (w/wo connector)
  65 reports
• Portex 100/111/025

  Tube, tracheal (w/wo connector)
  1 recall13 reports
• Portex 100/141/030

  Tube, tracheal (w/wo connector)
  1 recall13 reports
• Portex 101/860/070CZ

  Tube, tracheostomy (w/wo connector)
  60 reports
• Portex 100/189/070

  Tube, tracheal (w/wo connector)
  1 death57 reports
• Portex 100/111/030

  Tube, tracheal (w/wo connector)
  1 recall6 reports
• Portex 100/126/030

  Tube, tracheal (w/wo connector)
  1 recall6 reports
• Portex 100/111/035

  Tube, tracheal (w/wo connector)
  1 recall5 reports
• Portex 100/141/025

  Tube, tracheal (w/wo connector)
  1 recall5 reports
• Portex 100/127/025

  Tube, tracheal (w/wo connector)
  1 recall5 reports
• Portex 100/179/075

  Tube, tracheal (w/wo connector)
  55 reports
• Portex 100/126/025

  Tube, tracheal (w/wo connector)
  1 recall5 reports
• Portex 101/870/080CZ

  Tube, tracheostomy (w/wo connector)
  55 reports
• Portex 4599P-1

  Tubes, vials, systems, serum separators, blood collection
  1 recall2 reports
• Portex 4084P-1

  Tubes, vials, systems, serum separators, blood collection
  1 recall2 reports
• Portex 21-1530

  SPIROMETER, THERAPEUTIC (INCENTIVE)
  1 recall1 report
• Portex 100/111/020

  Tube, tracheal (w/wo connector)
  1 recall1 death1 report
• Portex 100/127/030

  Tube, tracheal (w/wo connector)
  1 recall1 report
• Portex 4044EG-1

  Tubes, vials, systems, serum separators, blood collection
  1 recall0 reports
• Portex 100/105/025

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex 100/105/030

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex 100/105/035

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex 100/141/035

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex 100/127/035

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex 100/126/035

  Tube, tracheal (w/wo connector)
  1 recall0 reports
• Portex A3595

  Anesthesia conduction kit
  1 recall0 reports
• Portex 4080P-2

  Tubes, vials, systems, serum separators, blood collection
  1 recall0 reports
• Portex 4080PE

  Tubes, vials, systems, serum separators, blood collection
  1 recall0 reports
• Portex A3729-24

  Anesthesia conduction kit
  1 recall0 reports
• Portex 4080PG

  Tubes, vials, systems, serum separators, blood collection
  1 recall0 reports
• Portex 198-35L

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  48 reports
• Portex 100/166/080

  Tube, tracheal (w/wo connector)
  44 reports
• Portex 198-37L

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  44 reports
• Portex 100/179/070

  Tube, tracheal (w/wo connector)
  38 reports
• Portex 101/858/080

  Tube, tracheostomy (w/wo connector)
  36 reports
• Portex G1460J

  Tubes, vials, systems, serum separators, blood collection
  35 reports
• Portex 101/870/075CZ

  Tube, tracheostomy (w/wo connector)
  33 reports
• Portex NLD-15597-20

  Anesthesia conduction kit
  32 reports
• Portex G1467J

  Tubes, vials, systems, serum separators, blood collection
  31 reports
• Portex 100/199/085

  Tube, tracheal (w/wo connector)
  31 reports
• Portex 100/166/075

  Tube, tracheal (w/wo connector)
  30 reports
• Portex 101/860/090CZ

  Tube, tracheostomy (w/wo connector)
  30 reports
• Portex 100/870/080CZ

  Tube, tracheostomy (w/wo connector)
  1 death28 reports
• Portex 101/870/070CZ

  BAG, RESERVOIR
  28 reports
• Portex 100/199/065

  Tube, tracheal (w/wo connector)
  26 reports
• Portex 101/860/085CZ

  Tube, tracheostomy (w/wo connector)
  25 reports
• Portex 100/136/050

  Tube, tracheal (w/wo connector)
  24 reports
• Portex 198-32L

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  24 reports
• Portex 4043E

  Tubes, vials, systems, serum separators, blood collection
  23 reports
• Portex 49661C-25

  Anesthesia conduction kit
  21 reports
• Portex 100/897/080CZ

  Tube, tracheostomy (w/wo connector)
  21 reports
• Portex 101/563/080

  Tube, tracheostomy (w/wo connector)
  21 reports
• Portex 4558PG

  Tubes, vials, systems, serum separators, blood collection
  21 reports
• Portex 526070

  Tube, tracheostomy (w/wo connector)
  20 reports
• Portex NEPI-NLD-15545C-21

  Anesthesia conduction kit
  20 reports
• Portex 4917M-19

  Anesthesia conduction kit
  19 reports
• Portex 100/179/055

  Tube, tracheal (w/wo connector)
  18 reports
• Portex 100/133/075

  Tube, tracheal (w/wo connector)
  17 reports
• Portex 24-1300-22

  Anesthesia conduction kit
  15 reports
• Portex 4558PE

  Tubes, vials, systems, serum separators, blood collection
  15 reports
• Portex 100/870/080

  Tube, tracheostomy (w/wo connector)
  14 reports
• Portex 100/597/080CZ

  Tube, tracheostomy (w/wo connector)
  14 reports
• Portex 503060

  Tube, tracheal (w/wo connector)
  13 reports
• Portex 450954-NL

  Filter, bacterial, breathing-circuit
  13 reports
• Portex 100/541/080CZ

  Tube, tracheostomy (w/wo connector)
  13 reports
• Portex 100/897/090CZ

  Tube, tracheostomy (w/wo connector)
  13 reports
• Portex G1469J

  Tubes, vials, systems, serum separators, blood collection
  12 reports
• Portex 101/815/080

  Tube, tracheostomy (w/wo connector)
  12 reports
• Portex 4042E

  Tubes, vials, systems, serum separators, blood collection
  12 reports
• Portex 100/399/218

  CATHETER, CONDUCTION, ANESTHETIC
  11 reports
• Portex 100/136/070

  Tube, tracheal (w/wo connector)
  11 reports
• Portex 100/166/070

  Tube, tracheal (w/wo connector)
  11 reports
• Portex 101/860/060CZ

  Tube, tracheostomy (w/wo connector)
  11 reports
• Portex 101/870/085CZ

  Tube, tracheostomy (w/wo connector)
  1 death11 reports
• Portex NEPI-NLD-15597C-20

  Anesthesia conduction kit
  11 reports
• Portex Z210-14

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  10 reports
• Portex 100/897/080

  Tube, tracheostomy (w/wo connector)
  1 death10 reports
• Portex 100/897/070CZ

  Tube, tracheostomy (w/wo connector)
  10 reports
• Portex 24-1301-22

  Anesthesia conduction kit
  10 reports
• Portex 101/870/090CZ

  Tube, tracheostomy (w/wo connector)
  10 reports
• Portex 101/810/080CZ

  Tube, tracheostomy (w/wo connector)
  10 reports
• Portex NLD-15545C-21

  Anesthesia conduction kit
  10 reports
• Portex 49662-25

  Anesthesia conduction kit
  9 reports
• Portex 503070

  Tube, tracheal (w/wo connector)
  9 reports
• Portex 100/897/070

  Tube, tracheostomy (w/wo connector)
  1 death9 reports
• Portex 101/563/090

  Tube tracheostomy and tube cuff
  9 reports
• Portex 526060

  Tube, tracheostomy (w/wo connector)
  8 reports
• Portex 66-1991

  CONNECTOR, AIRWAY (EXTENSION)
  8 reports
• Portex 100/136/075

  Tube, tracheal (w/wo connector)
  8 reports
• Portex 100/179/080

  IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS
  8 reports
• Portex 450952-NL

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  8 reports

Recent Portex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952824 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Code Blue, the patient had no heartbeat and Cardiopulmonary Resuscitation (CPR) and intubation were initiated. During an intubation attempt, the tracheal tube cuff inflation bulb reportedly burst, preventing cuff inflation and causing a delay of less than five minutes. Ventilation was maintained with a BVM/Ambu bag between attempts. Return of Spontaneous Circulation (ROSC) was not achieved, and the patient expired. The reporter stated that the death was not related to the device; however, patient harm was reported, while noting that it has not been established whether the harm was caused by our device.

  Patient problems: Insufficient Information

  MAUDE report 50937144 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Code Blue, the patient had no heartbeat and Cardiopulmonary Resuscitation (CPR) and intubation were initiated. During an intubation attempt, the tracheal tube cuff inflation bulb reportedly burst, preventing cuff inflation and causing a delay of less than five minutes. Ventilation was maintained with a BVM/Ambu bag between attempts. Return of Spontaneous Circulation (ROSC) was not achieved, and the patient expired. The reporter stated that the death was not related to the device; however, patient harm was reported, while noting that it has not been established whether the harm was caused by our device.

  Patient problems: Insufficient Information

  MAUDE report 50937075 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905008 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904985 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892657 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889519 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889232 ↗
• MalfunctionSep 23, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876427 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846434 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846397 ↗
• InjurySep 21, 2026Complete Blockage

  Patient problems: Respiratory Insufficiency

  MAUDE report 50843035 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  It was reported that an air leak was observed from the cuff while the device was in use during an infusion at the healthcare facility. The event involved the patient; however, no patient harm or adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839679 ↗
• MalfunctionSep 18, 2026Gas/Air Leak

  It was reported that the patient was switched to a new nasotracheal tube and connected to a ventilator. Later, the ventilator alarm indicated an air leak. The tracheal tube was replaced, and the cuff was found to be damaged. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818128 ↗
• MalfunctionSep 17, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811293 ↗

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