CLEARLINK/DUO-VENTRecalls & reported problems across all models

We found 3 models of CLEARLINK/DUO-VENT by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2018 and Sep 24, 2026 — classified as 1 death, 149 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (99 reports).

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

Most reported CLEARLINK/DUO-VENT problems

CLEARLINK/DUO-VENT models

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

• CLEARLINK/DUO-VENT 2R8480

  Set, administration, intravascular
  1 death73 reports
• CLEARLINK/DUO-VENT 2H7462

  Set, administration, intravascular
  47 reports
• CLEARLINK/DUO-VENT 2C8851

  Set, administration, intravascular
  30 reports

Recent CLEARLINK/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 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 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET LEAKED FROM THE Y-SITE. THIS OCCURRED DURING INFUSION OF AMINO ACIDS WHILE THE REPORTER WAS ATTEMPTING TO HANG TOTAL PARENTERAL NUTRITION (TPN). THE REPORTER WAS HAVING TROUBLE GETTING THE SECOND FILTER PRIMED, SO THEY WERE USING THE PUMP TO PRIME THIS LAST BIT OF TUBING. WHEN THE REPORTER STARTED THE UNSPECIFIED INFUSION PUMP, THEY NOTICED THE AMINO ACID SOLUTION WAS LEAKING OUT OF THE Y-SITE WHERE THE LIPIDS WOULD BE CONNECTED. THE SPECIFIC INFUSION RATE WAS UNKNOWN, BUT WAS REPORTED AS ¿LESS THAN 75 ML/HR¿. 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 25641088 ↗
• 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 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NITROGLYCERIN SET WITH DUO-VENT SPIKE LEAKED AROUND THE SPIKE AREA. THE CUSTOMER REPORTED, ¿SMOF BAG SPIKED AS PER NORMAL AND TUBING PRIMED. SMOF NOTED TO BE LEAKING AROUND SPIKE. VERY DIFFICULT TO INSERT SPIKE FAR ENOUGH TO GET LEAKING TO STOP. UNKNOWN AMOUNT OF SMOF LOST.¿ THIS OCCURRED DURING PREPARATION OF A LIPID INJECTABLE EMULSION (SMOF) INFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879403 ↗
• MalfunctionApr 14, 2026Disconnection; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPIKE OF A NON-DEHP SOLUTION SET WITH DUO-VENT SPIKE FELL OFF OF AN AMINO ACID BAG. WHEN THE BAG WAS HUNG, THE SPIKE CAME OUT OF THE BAG, LEADING TO A 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 24879295 ↗
• MalfunctionJan 28, 2026Backflow

  IT WAS REPORTED THAT LIPID BACKED UP INTO A CLEARLINK, NON-DEHP SOLUTION SET (PARENTERAL NUTRITION (PN) LINE). THE ISSUE OCCURRED DURING PATIENT INFUSION VIA A CENTRAL VENOUS CATHETER (CVC). THERE WAS AN ATTEMPT TO LIFT THE LINES FOR GRAVITY TO MOVE THE SOLUTION FORWARD WITH NO IMPROVEMENT. THE PN LINE WAS CHANGED TO RESOLVE THE ISSUE. 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 24204776 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET LEAKED PARENTERAL NUTRITION (PN) FROM WHERE THE BAG WAS SPIKED AND THE SOLUTION WAS RUNNING DOWN THE INTRAVENOUS (IV) LINE. THE ISSUE OCCURRED APPROXIMATELY 8 HOURS INTO A PATIENT INFUSION VIA AN IV PUMP AT A FLOW RATE OF 4.31ML/HR. TO RESOLVE THE EVENT, PN WAS STOPPED AND NORMAL SALINE WAS RUN AT THE SAME RATE (4.31ML/HR) AS A CHASER FOR LIPID. 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 24133275 ↗
• MalfunctionJan 16, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET WITH DUO-VENT SPIKE DISCONNECTED FROM AN AMINO ACID BAG WHICH RESULTED IN A FLUID LEAK. THE LUER LOCK DISCONNECTED FROM THE AMINO ACID FILTER LINE ATTACHED TO ONE OF THE LUMENS ON A TRIPLE LUMEN IV EXTENSION PIECE WHICH WAS ATTACHED TO A CENTRAL 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 24102582 ↗
• MalfunctionJan 3, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS OVER-INFUSED WHILE BEING USED WITH SPECTRUM INFUSION PUMPS. THE INFUSIONS WERE COMPLETED APPROXIMATELY 1 TO 3 HOURS EARLIER THAN THE INTENDED DURATION. THESE OCCURRED WHILE THE PATIENTS WERE RECEIVING TOTAL PARENTERAL NUTRITION (TPN) VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). TO PREVENT HYPOGLYCEMIA, A DEXTROSE 5% (D5) INFUSION WAS PROMPTLY INITIATED. 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 23953057 ↗
• MalfunctionJan 3, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS OVER-INFUSED WHILE BEING USED WITH SPECTRUM INFUSION PUMPS. THE INFUSIONS WERE COMPLETED APPROXIMATELY 1 TO 3 HOURS EARLIER THAN THE INTENDED DURATION. THESE OCCURRED WHILE THE PATIENTS WERE RECEIVING TOTAL PARENTERAL NUTRITION (TPN) THROUGH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). TO PREVENT HYPOGLYCEMIA, A DEXTROSE 5% (D5) INFUSION WAS PROMPTLY INITIATED. 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 23953055 ↗
• DeathNov 26, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A SPECTRUM IQ INFUSION PUMP INFUSED AMIODARONE AT A SIGNIFICANTLY ACCELERATED RATE, WHICH DID NOT ALIGN WITH THE PROGRAMMED DOSAGE. A CLEARLINK, NON-DEHP SOLUTION SET WAS USED TO ADMINISTER THE MEDICATION. IT WAS ALLEGED THE PATIENT HAD SUBSEQUENTLY PASSED AWAY. THE EVENT OCCURRED IN THE CRITICAL INTENSIVE CARE UNIT (CICU). THE PUMP WAS PROGRAMMED TO INFUSE AMIODARONE (450MG, 1.8MG/ML) AT A RATE OF 33.33ML/HOUR OR 1MG/MINUTE FOR A VOLUME TO BE INFUSED OF 250ML AT ROOM TEMPERATURE. THE AMIODARONE BAG SIZE WAS 250ML. THE INFUSION WAS SUPPOSED TO LAST 7.5 HOURS BUT INFUSED IN LESS THAN 3 HOURS ON THE FIRST BAG AND LESS THAN 2 HOURS ON THE SECOND BAG. THE CLEARLINK WAS IN USE FOR 2 HOURS WITH NO IV SET ADD-ON COMPONENTS USED. THE ADMINISTRATION SET UPSTREAM OF THE PUMP DID NOT APPEAR COLLAPSED OR DEFORMED. IT WAS FURTHER REPORTED THAT THERE WERE OTHER INFUSION SYSTEMS CONNECTED AT THE SAME ACCESS POINT; HOWEVER, NO SPECIFIC INFORMATION WAS PROVIDED. IT WAS NOT REPORTED IF ANY LIFE SUSTAINING TREATMENT WAS PROVIDED OR IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION IS EXPECTED REGARDING PATIENT¿S MEDICAL CONDITION, PAST MEDIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23659076 ↗
• MalfunctionNov 13, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH THREE (3) CLEARLINK NON-DEHP SOLUTION SETS WITH DUO-VENT SPIKE. DURING DOXIL INFUSION, THE MEDICATION FLOW CEASED APPROXIMATELY 15 MINUTES AFTER INITIATION. ATTEMPTS TO RESTORE FLOW VIA FREE-FLOW WERE UNSUCCESSFUL. THE PHARMACY REPLACED THE TUBING TWICE MORE; HOWEVER, THE ISSUE RECURRED AFTER APPROXIMATELY 15 MINUTES EACH TIME. THE INFUSION WAS SUBSEQUENTLY SWITCHED TO STANDARD TUBING, AFTER WHICH NO FURTHER INTERRUPTIONS OCCURRED. 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 23543212 ↗
• 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 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• ONE-LINK12 models · 638 reports · 1 recall
• CLEARLINK19 models · 359 reports · 4 recalls
• INTRAVIA7 models · 455 reports
• INTERLINK17 models · 129 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports
• PrismaSATE2 models · 1 reports · 1 recall