DUO-VENTRecalls & reported problems across all models

We found 5 models of DUO-VENT by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Sep 9, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

DUO-VENT 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. 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 ↗

2. Dec 20, 2024Open, Classified

   Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

   Z-1009-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported DUO-VENT problems

DUO-VENT models

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

• DUO-VENT 2R8404

  Set, administration, intravascular
  1 recall21 reports
• DUO-VENT 1C8507

  Set, administration, intravascular
  1 recall4 reports
• DUO-VENT ACT5435

  Set, administration, intravascular
  3 reports
• DUO-VENT ACT5439

  Set, administration, intravascular
  2 reports
• DUO-VENT 2C7552

  Set, administration, intravascular
  1 report

Recent DUO-VENT adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50289513 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPOTED THAT A SOLUTION SET WITH DUO-VENT SPIKE LEAKED AT THE LOWER WHITE RUBBER REINFORCEMENT PIECE ABOVE THE LUER LOCK AND BELOW THE BLUE CLAMP WHERE THE TUBING IS INSERTED INTO THE PUMP. THIS WAS OBSERVED DURING USE. 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 23996657 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WITH DUO-VENT SPIKE "BROKE OFF" AND THE DILUENT LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS SEPARATION OF BONDED COMPONENTS; THE TUBING SEPARATED AT AN UNSPECIFIED LOCATION. THE EVENT OCCURRED DURING SETUP WHEN THE DEVICE WAS BEING PRIMED WITH 0.9% SODIUM CHLORIDE INJECTION IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527688 ↗
• MalfunctionJul 25, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WITH DUO-VENT SPIKE HAD DETACHED AT A WHITE CONNECTION POINT (TUBING SEGMENT) RESULTING IN A LEAK; FLUID LEAKED ON THE NURSE'S HAND. THE ISSUE WAS NOTICED APPROXIMATELY AFTER 7 MIN/26 ML INTO THE DOSTARLIMAB INFUSION WHEN THE NURSE CAME TO ATTACH A PUMP TO THE POLE. THE INFUSION WAS INTERRUPTED, THE DOSE WAS RE-DISPENSED, AND A NEW TUBING SET WAS USED TO RESOLVE THE EVENT. 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 22621021 ↗
• MalfunctionJul 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BLUE CLIP (SLIDE CLAMP) OF A SOLUTION SET WAS INSTALLED BACKWARD ON THE TUBING. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22570975 ↗
• 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 ↗
• MalfunctionMay 6, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF SOLUTION SETS WITH DUO-VENT SPIKE HAD AN INVERTED SLIDE CLAMP. THIS WAS DISCOVERED DURING PUMP SET UP. THE "KEY WAS BACKWARDS AND DEFECTIVE" PREVENTING THE TUBING FROM BEING SET UP CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969565 ↗
• MalfunctionDec 12, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE WAS ASSEMBLED INCORRECTLY. THE DARK BLUE SLIDE CLAMP WAS ON BACKWARDS AND THE TUBING HAD TO BE TWISTED TO USE IT. THIS ISSUE WAS DISCOVERED DURING USE WHILE ATTEMPTING TO USE FOR CHEMOTHERAPY. 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 20916225 ↗
• MalfunctionDec 11, 2024Filling Problem; Protective Measures Problem; Filling Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PUMP IN USE WITH A SOLUTION SET WITH DUO-VENT SPIKE ALARMED "UPSTREAM OCCLUSION", "AIR IN LINE" AND "MAX AIR DETECTED". THIS OCCURRED DURING INFUSION WITH UNSPECIFIED CHEMOTHERAPY. THE PUMP WAS CHANGED AND THE SAME ALARMS OCCURRED WHEN USED WITH THE SAME TUBING. THE INFUSION COMPLETED IN TWO HOURS INSTEAD OF ONE HOUR. 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 20905907 ↗
• MalfunctionDec 11, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF SOLUTION SETS WITH DUO-VENT SPIKE WERE INCORRECTLY ASSEMBLED. THIS ISSUE WAS DESCRIBED AS THE ¿KEY¿ WAS NOT ORIENTED IN THE APPROPRIATE MANNER. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. 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 20905671 ↗
• MalfunctionDec 10, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE WAS ASSEMBLED INCORRECTLY. IT WAS OBSERVED THAT THE BLUE SIDE CLAMP WAS THREADED BACKWARD AND THEREFORE DID NOT FIT IN THE PUMP. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894458 ↗
• MalfunctionNov 14, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE LABELING ('BLUE INK') ON AN UNSPECIFIED AMOUNT OF SOLUTION SET WITH DUO-VENT SPIKE PACKAGES WERE SMUDGED. THIS WAS OBSERVED WHEN THE PACKAGING WAS WIPED DOWN WITH ALCOHOL PRIOR TO OPENING THE PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684648 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING OF A SOLUTION SET WITH DUO-VENT SPIKE WHICH RESULTED IN A MEDICATION LEAK. THE HOLE IN THE TUBING AND FLUID LEAK WAS DISCOVERED WHILE INFUSION AN UNSPECIFIED CHEMOTHERAPY. 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 20456185 ↗
• 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 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports