DUO-VENT 1C8507Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412014319), received between Oct 12, 2022 and Sep 9, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

12 other recalls cover devices cleared under the same FDA submission (K203609, K961225); 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.

Recalls naming this device

1. Jun 30, 2026Open, Classified

   Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

   Z-2766-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Filling Problem; Air/Gas in Device

  It was reported that a Solution Set with DUO-VENT Spike overinfused and exhibited air in line during a propofol infusion programmed at (b)(6)/hour. The reporter stated that the patient required a change of propofol and tubing. The previous medication bag and administration set were removed from the Novum pump, and a new medication bag and tubing were prepared. The infusion rate was not changed, and the volume to be infused (VTBI) was adjusted to (b)(6). The infusion was initiated without issue; however, approximately one hour later, the pump alarmed for "air in line." While the alarm was sounding, the bedside nurse reportedly heard a noise suggesting that the pump was still running. Upon assessment, air in line was observed lower in the tubing than expected and the propofol bag was found to be empty. The pump was immediately stopped and the patient was assessed. The reporter stated that the patient's status and vital signs remained stable. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692233 ↗
• MalfunctionJun 12, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE HAD SIGNIFICANT AMOUNT OF AIR IN THE LINE. THIS WAS OBSERVED WHEN THE PUMP WAS STARTED AFTER AN EMPTY FENTANYL INFUSION WAS CHANGED TO A NEW BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197671 ↗
• MalfunctionOct 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE WAS OBSERVED TO BE SLICED IN TWO DIFFERENT SECTIONS OF THE TUBING. THIS OCCURRED WHILE OPENING THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419008 ↗
• InjuryOct 12, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PATIENT INFUSION OF EPOPROSTENOL WITH A DUO-VENT SOLUTION SET, A SMALL HOLE IN THE TUBING WAS OBSERVED. IT WAS FURTHER REPORTED BLOOD BACKED UP INTO THE TUBING AND THE PATIENT BECAME ¿HYPOTENSIVE AND SHORT OF BREATH¿. PHENYLEPHRINE WAS ADMINISTERED ¿TO SUPPORT THE BLOOD PRESSURE¿ AND THE EXTRA-CORPOREAL MEMBRANE OXYGENATION SETTINGS WERE "INCREASED TO SUPPORT THE PATIENT". ACCORDING TO THE REPORTER, ¿NO APPARENT FORCE WAS APPLIED TO THE TUBING; THIS APPEARED TO HAPPEN SPONTANEOUSLY". AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 15587050 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0192-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
• Z-0194-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0193-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-2594-2025 · Aug 8, 2025 · Open, Classified
  Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration s
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
• Z-0794-2020 · Dec 12, 2019 · Open, Classified
  ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Pro
• Z-0793-2020 · Dec 12, 2019 · Open, Classified
  Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vas
• Z-0475-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2920-2011 · Jul 21, 2011 · Terminated
  Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-1152-03 · Jul 16, 2003 · Terminated
  Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3 injection sites, Male Luer Lock Adapter, catalog 2C6521; Baxter Healthcare Corporation, Deerf