CLEARLINK/DUO-VENT 2H7462Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00085412048543), received between Apr 26, 2018 and Sep 24, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Unexpected Color

  It was reported that two (2) CLEARLINK Secondary Medication Sets appeared foggy during patient infusion. One set was used with Magnesium connected to a primary Normal Saline infusion, and the other set was used with an unspecified intravenous antibiotic. 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 50878514 ↗
• MalfunctionAug 21, 2026Backflow; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383042 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SECONDARY MEDICATION SET LEAKED AT THE JUNCTION BETWEEN THE LUER ADAPTER AND A NON-BAXTER TUBING SET. THIS OCCURRED DURING A CYTOTOXIC DRUG INFUSION. THE REPORTER STATED THAT ALTHOUGH THE TUBING WAS PROPERLY SCREWED ON, THE LEAK APPEARED UNDER PRESSURE WHEN THE PUMP WAS STARTED. 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 25242111 ↗
• MalfunctionNov 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ROLLER CLAMP OF A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET WAS INSTALLED UPSIDE DOWN ON THE TUBING. THIS ISSUE WAS NOTICED WHILE INSPECTING THE DEVICE AFTER THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459314 ↗
• MalfunctionOct 1, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT MULTIPLE UNITS OF CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS HAD NO FLOW. THIS OCCURRED DURING PATIENT 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 23197077 ↗
• MalfunctionJun 24, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A NON-BAXTER PUMP WAS STATING UPSTREAM OCCLUSION WHILE BEING USED WITH AN UNSPECIFIED AMOUNT OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS. THE ISSUE OCCURRED DURING PATIENT INFUSION WHILE RUNNING INTRAVENOUS IMMUNOGLOBULIN(IVIG) WITH A BOTTLE (30ML). 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 22319628 ↗
• MalfunctionJun 20, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD AN UPSTREAM OCCLUSION. THIS WAS OBSERVED WHILE RUNNING INTRAVENOUS IMMUNOGLOBULIN. 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 22301902 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET LEAKED FROM WHERE THE TUBING CONNECTS TO THE DRIP CHAMBER. THIS OCCURRED 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 21904319 ↗
• MalfunctionDec 2, 2024Backflow; Backflow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET BACKFILLED INTO A CLEARLINK SYSTEM CONTINU-FLO PRIMARY SOLUTION SET. THE PIGGYBACK SECONDARY SET WAS CONNECTED TO THE PRIMARY SET DURING INFUSION WHEN IT WAS OBSERVED THAT THE INFUSION WAS NOT GOING TO THE PATIENT BUT BACKFILLED INTO THE PRIMARY TUBING CHAMBER. TO RESOLVE THIS ISSUE, ¿HOOKED THE TUBING UP DISTAL TO THE ROLLER CLAMP AND TURNED THE ROLLER CLAMP OFF TO THE PRIMARY SOLUTION TO ALLOW THE MEDICATION TO INFUSE¿. 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 20819729 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET LEAKED FROM AN UNSPECIFIED LOCATION WHILE IN USE WITH THE CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THE PRIMARY TUBING WAS PRIMED WITH NORMAL SALINE, AND THE SECONDARY TUBING WITH ACETAMINOPHEN. WHEN THE PROGRAMMED PUMP STARTED TO RUN THE ACETAMINOPHEN, BOTH THE PRIMARY AND SECONDARY TUBING LEAKED. 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 20781877 ↗
• MalfunctionNov 5, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A 'SPACE' WAS FORMED BETWEEN THE SPIKE OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS AND NON-BAXTER SOLUTION BAG PORTS; THERE WAS NO SOLUTION SPILLAGE. THIS WAS OBSERVED DURING USE OF THE 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 20614096 ↗
• MalfunctionOct 24, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET DISCONNECTED FROM A NON-BAXTER 250ML SODIUM CHLORIDE 0.9% BAG RESULTING IN A LEAK. THE PATIENT WAS BEING PREPARED FOR CHEMOTHERAPY TREATMENT (PEMETREXED).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 20529891 ↗
• MalfunctionOct 24, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET DETACHED FROM THE NON-BAXTER 100ML SODIUM CHLORIDE 0.9% BAG RESULTING IN A SPILL. THIS WAS OBSERVED DURING INSTALLATION OF THE BAG ON THE POLE BY THE NURSE. THE PATIENT WAS BEING PREPARED FOR A CHEMOTHERAPY INFUSION (PEMETREXED). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528839 ↗
• MalfunctionOct 17, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SECONDARY MEDICATION SETS DISCONNECTED FROM THE IV (INTRAVENOUS) BAG WHICH RESULTED IN CHEMOTHERAPY LEAKAGE. THIS OCCURRED DURING SET UP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474291 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WITH DUO-VENT SPIKE LEAKED FROM THE AIR VENT. THE NURSE OPENED THE AIR INTAKE AND UNSPECIFIED CHEMOTHERAPY LEAKED OUT OF THE SET. THIS OCCURRED DURING THE END OF TREATMENT. 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 20446826 ↗
• MalfunctionJun 21, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING USE OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS, THERE WAS DIFFICULTY TO INFUSE THE SOLUTION. 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 19588666 ↗
• MalfunctionJun 19, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING USE OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS, THERE WAS DIFFICULTY TO INFUSE THE SOLUTION; THE VENTS WERE OPENED TO INFUSE THE PRODUCT. THIS WAS OBSERVED DURING USE OF THE SECONDARY SETS WITH NON-BAXTER PRIMARY SETS; GLASS BOTTLES AND FLEXIBLE CONTAINERS WERE PART OF THE SET UP. WITH THE GLASS BOTTLES, THERE WAS INSUFFICIENT AIR VENTILATION. 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 19568543 ↗
• MalfunctionJun 18, 2024No Flow; No Flow

  IT WAS REPORTED THAT AN CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET FAILED TO INFUSE DESPITE THE CLAMP BEING OPEN. THE PRIMARY INFUSION RAN DRY WHICH ALERTED THE NURSE, THEY REMOVED THE AIR, AND REATTACHED THE MESNA TO COMPLETE THE INFUSION. THE EVENT OCCURRED APPROXIMATELY AN HOUR INTO THE 4-HOUR MESNA 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 19563754 ↗
• MalfunctionJan 31, 2024Crack; Crack

  IT WAS REPORTED THAT A CLEAR LINK DUO-VENT SECONDARY MEDICATION SET HAD A BROKEN SPIKE. THE EVENT WAS FURTHER DESCRIBED AS, "THE SPIKE FROM THE SECONDARY TUBING SNAPPED OFF IN THE CONNECTION PIECE". THE DEVICE CONTAINED GANCICLOVIR. 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 18614347 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK DUO-VENT SECONDARY MEDICATION SETS LEAKED. THIS OCCURRED 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 18398076 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK DUO-VENT SECONDARY MEDICATION SET LEAKED AT THE AIR INTAKE OPENING CLIP DURING AN UNSPECIFIED PROCESS STEP. CHEMOTHERAPY LEAKED ON THE POLE TO THE GROUND. 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 18398032 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK DUO-VENT SECONDARY MEDICATION SETS LEAKED SALINE. THIS WAS IDENTIFIED BY THE NURSE 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 18398029 ↗
• MalfunctionOct 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY [AT LEAST THREE (3)] OF CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS LEAKED AT THE AIR INTAKE CLIP. CHEMOTHERAPY LEAKED FROM THE POLE TO THE FLOOR. SALINE LEAKS WERE FIRST DETECTED BY THE NURSE. AFTER CHEMOTHERAPY INFUSION WAS STARTED, LIQUID LEAKED THROUGH THE AIR GAP. 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 18033350 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SETS LEAKED. THE LEAKS WERE AT THE AIR INTAKE CLIP NORMALLY USED FOR SECONDARY INFUSION. SALINE AND CHEMOTHERAPY LEAKED FROM THE POLE TO THE FLOOR. THE ISSUE WAS OBSERVED DURING PATIENT 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 17987356 ↗
• MalfunctionJun 16, 2023No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK NON-DEHP SECONDARY MEDICATION SETS WERE ¿NOT FLOWING CORRECTLY¿ AND THE ¿PRODUCT WAS JAMMING UP IN THE LINE¿. THIS OCCURRED 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 17148681 ↗

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-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-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-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-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-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-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