CLEARLINK/DUO-VENT 2C7462Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00085412048475), received between Feb 23, 2018 and Sep 7, 2026 — classified as 1 injury, 56 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650950 ↗
• MalfunctionAug 26, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460760 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459564 ↗
• MalfunctionJun 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD HAIR OR FIBER INSIDE CHAMBER, HALF COMPRESSED INTO ATTACHMENT POINT AND THE PARTICULATE MATTER WAS LOCATED INSIDE THE FLUID PATH. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353262 ↗
• MalfunctionFeb 25, 2026No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS HAD DIFFICULTY RUNNING IVIG (INTRAVENOUS IMMUNOGLOBULIN) AND ALBUMIN. A PUMP WAS USED IN CONJUNCTION WITH THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448803 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET LEAKED CHEMO FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING PATIENT 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 23439560 ↗
• MalfunctionOct 31, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE SPIKES OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WERE FALLING OUT AFTER SPIKING UNSPECIFIED BAGS. 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 23436165 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE BACK-CHECK VALVE OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WERE BROKEN. THIS WAS DISCOVERED 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 23435972 ↗
• MalfunctionOct 29, 2025Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE SPIKES OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WERE FALLING OUT AFTER SPIKING NON-BAXTER BAGS. THE EVENT WAS FURTHER DESCRIBED AS UNSPECIFIED DAMAGE. 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 23420501 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SECONDARY MEDICATION SETS WITH DUO-VENT SPIKE WERE LEAKING FROM THE FILTER. THE LEAKS OCCURRED DURING PATIENT INFUSION OF CEFEPIME AND 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 23327927 ↗
• MalfunctionOct 17, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN OVER INFUSION OF MEDICATION OCCURRED DURING THE USE OF A CLEARLINK SECONDARY MEDICATION SET WITH DUO-VENT SPIKE. IT WAS OBSERVED THAT A CEFEPIME BAG WAS COMPLETELY INFUSED FASTER THAN THE EXPECTED THERAPY TIME. THIS ISSUE 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 23327594 ↗
• MalfunctionJun 17, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) CLEARLINK SYSTEM SECONDARY MEDICATION SETS BROKE AT THE PORTS. THERE WERE CRACKING AT THE PORTS AND LEAKS. 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 22236379 ↗
• MalfunctionJun 13, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEUR LOCK OF A SECONDARY MEDICATION SET BROKE OFF AND ALLOWED FREE FLOW OF INTRAVENOUS (IV) FLUIDS AND MEDICATION OUT OF THE LEUR LOCK SITE. THIS WAS OBSERVED DURING PATIENT 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 22206044 ↗
• MalfunctionJun 10, 2025Filling Problem; No Flow; Filling Problem; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS DID NOT ALLOW FOR THE FULL MEDICATION TO INFUSE APPROPRIATELY. THIS WAS NOTICED DURING USE OF THE DEVICES. THE EVENT WAS DESCRIBED AS, "MEDICATION NOT PULLING FROM SECONDARY LINE WHEN PUMP INFUSING." 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 22181208 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Free or Unrestricted Flow; Fluid/Blood Leak; Free or Unrestricted Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET LEAKED MEDICATION OUT OF THE TUBING. 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 22172069 ↗
• MalfunctionJun 9, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT MEDICATION WAS NOT FLOWING THROUGH AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS. IT WAS OBSERVED THAT MEDICATION WAS NOT PULLING FROM THE SECONDARY LINE WHILE THE NON-BAXTER PUMP WAS INFUSING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿SECONDARY TUBING DOES NOT ALLOW FOR FULL MEDICATION TO INFUSE APPROPRIATELY¿. 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 22170895 ↗
• MalfunctionMay 29, 2025Break; Fluid/Blood Leak; Detachment of Device or Device Component; Break; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS EITHER HAD "BREAKAGE AT PORTS"," LEAKS" OR "TUBING BREAKING APART". THE PROCESS STEP WAS NOT SPECIFIED. 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 22107322 ↗
• MalfunctionMay 15, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE ROLLER CLAMP OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WERE NOT FULLY CLAMPING THE LINE. 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 22031127 ↗
• MalfunctionMay 13, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET DID NOT INFUSE ANTIBIOTICS. THE TUBING WAS NOT PULLING FLUID FROM THE ANTIBIOTIC BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009649 ↗
• MalfunctionMay 9, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LUER LOCK OF THREE (3) CLEARLINK SYSTEM SECONDARY MEDICATION SETS BROKE AND LEAKED. THIS OCCURRED WHEN THE SET WAS DISCONNECTING FROM THE IV (INTRAVENOUS) ADMINISTRATION SET. 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 21994457 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SECONDARY MEDICATION SET BROKE. THIS ISSUE WAS DESCRIBED AS, ¿WHILE REMOVING THE SMALL BLUE CLAMPS DURING A TYLENOL IVPB ADMINISTRATION, THE PRIMARY LINE BROKE WHERE IT HAD BEEN CLAMPED. IT BROKE RIGHT UNDER THE FILTER AND THICKER AREA OF THE LINE¿. THIS OCCURRED IN THE HOSPITAL 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 21928423 ↗
• MalfunctionApr 25, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET DID NOT INFUSE ANTIBIOTICS. THE SET WAS NOT PULLING FLUID FROM AN ANTIBIOTIC BAG. 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 21913704 ↗
• MalfunctionApr 25, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THERE AIR WAS DETECTED IN THE LINE WHILE USING A CLEARLINK/DUO-VENT SECONDARY MEDICATION SET. AIR WAS DETECTED IN THE LINE DESPITE NO AIR BEING PRESENT. 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 21910512 ↗
• MalfunctionApr 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CLAMP WAS NOT FULLY CLOSING THE LINE OF A CLEARLINK/DUO-VENT SECONDARY MEDICATION SET. 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 21910510 ↗
• MalfunctionApr 25, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A SECONDARY MEDICATION SET LEAKED FROM THE SPIKE SITE. THIS WAS OBSERVED WHEN THE ANTIBIOTIC BAG WAS HUNG AFTER SPIKING. MULTIPLE ATTEMPTS WERE MADE TO GET THE SPIKE TO SIT IN THE ANTIBIOTIC BAG TO NOT LEAK. 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 21910420 ↗

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-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-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-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