DUO-VENT 2R8404Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00085412676630), received between Nov 21, 2023 and Aug 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K180739); 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. 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 problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BLUE SLIDE CLAMP/KEY OF A SOLUTION SET WITH DUO-VENT SPIKE WAS CUTTING INTO THE TUBING RESULTING IN A LEAK OF CHEMOTHERAPY. THIS WAS NOTICED 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 20180463 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THREE (3) SOLUTION SETS WITH DUO-VENT SPIKE LEAKED CHEMOTHERAPY FROM THE TUBING. THE BLUE SLIDE CLAMP KEY APPEARED TO HAVE SLICED THE TUBING AND CAUSED A HOLE, AND CHEMO BEGAN TO LEAK AT THAT POINT. THIS OCCURRED WHEN THE BLUE SLIDE CLAMP KEY WAS PULLED OUT OF THE PUMP. 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 20140463 ↗
• MalfunctionJul 24, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF AN UNSPECIFIED QUANTITY OF SOLUTION SETS, AIR IN LINE WAS OBSERVED. THE EVENT WAS FURTHER DESCRIBED AS "PULLS AIR OFTEN, CREATING AIR IN LINE". 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 19821162 ↗
• MalfunctionJul 24, 2024Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE OF AN UNSPECIFIED QUANTITY OF SOLUTION SETS, UPSTREAM OCCLUSION ALARMS WERE OBSERVED; KINKS WERE IDENTIFIED IN THE TUBING SETS. 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 19820843 ↗
• MalfunctionJul 3, 2024Backflow; Detachment of Device or Device Component; Backflow; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WITH DUO-VENT SPIKE CAME APART AND THERE WAS A BACKFLOW OF BLOOD INTO THE SET. THIS EVENT OCCURRED DURING INFUSION. 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 19669123 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOLUTION SET WITH A DUO-VENT SPIKE WAS LEAKING. THIS ISSUE WAS DESCRIBED AS, ¿CHEMO STARTED LEAKING THROUGH THE SECONDARY TUBING'S VALVE¿. THIS OCCURRED WHILE CONNECTING THE SECONDARY TUBING. 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 19617139 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM THE "CONNECTION JUST BELOW THE CHAMBER WHERE IT CONNECTS TO THE LONGER TUBING"; THERE WAS A SEPARATION OF BONDED COMPONENTS. THIS OCCURRED DURING PREPARATION, AFTER SPIKING AN INTRAVENOUS (IV) 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 19013461 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM THE "DRIP CHAMBER WHERE THE WHITE PLASTIC MEETS THE CLEAR PLASTIC". THIS OCCURRED DURING PRIMING OF THE TUBING WITH CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013131 ↗
• MalfunctionNov 21, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS INCORRECTLY ASSEMBLED. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿NOT PROPERLY THREADED THROUGH THE CORRECT AREA OF THE CLAMP¿. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180739. One submission often covers many models, so check the product and lot details in each record.

• Z-0203-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-i
• Z-0202-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
• Z-0201-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
• Z-1010-2025 · Dec 20, 2024 · Open, Classified
  Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
• Z-1291-2024 · Feb 8, 2024 · Open, Classified
  CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401