CLEARLINK/DUO-VENT 2R8480Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00085412565750), received between Sep 14, 2018 and Jun 26, 2026 — classified as 1 death, 72 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (61 reports).

2 other recalls cover devices cleared under the same FDA submission (K153158); 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 73 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 22, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK, NON-DEHP SOLUTION SET DETACHED FROM THE AMINO ACID (PN) BAG AND SOLUTION SPILLED OUT OF THE BAG. THIS OCCURRED WHILE PREPARING THE INFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878904 ↗
• MalfunctionMar 31, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP SOLUTION SETS HAD AIR BUBBLES. THIS WAS OBSERVED AFTER THE SETS WERE PRIMED AND THE NURSES GO TO HANG THE BAGS. THE NURSES HAD TO RE-PRIME THE TUBING; HOWEVER, PATIENT INVOLVEMENT 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 21733430 ↗
• MalfunctionJan 13, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN OVERINFUSION OF MEDICATION OCCURRED WHILE USING AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS. THE INFUSIONS ARE SET FOR 24 HOURS AND APPROXIMATELY 2L, BUT THE PUMPS ARE RUNNING OUT OF FLUID ABOUT 30 MINUTES EARLY AND DELIVERING 50-60 ML MORE THAN PRESCRIBED. THESE OVERINFUSIONS OCCURRED WITH SIGMA SPECTRUM PUMPS DURING TPN (TOTAL PARENTERAL NUTRITION) TREATMENTS. 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 21138690 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TUBING OF A CLEARLINK SOLUTION SET SEPARATED FROM THE LOWEST PART OF THE TUBING ONE PORT UP FROM WHERE IT CONNECTED TO THE PATIENT. THE DEVICE CONTAINED MAINTENANCE INTRAVENOUS FLUID. BLOOD WAS BACKING UP FROM UMBILICAL VENOUS CATHETER (UVC). 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 20801078 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SOLUTION SETS LEAKED BETWEEN THE BOTTOM OF THE DRIP CHAMBER AND THE TUBING. THIS OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579604 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK, NON-DEHP SOLUTION SET LEAKED AT THE SITE WHERE THE DRIP CHAMBER MEETS THE TUBING. THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579533 ↗
• MalfunctionSep 18, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT UNDERINFUSIONS OCCURRED DURING THE USE OF AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS. THIS ISSUE WAS FURTHER DESCRIBED AS MULTIPLE INSTANCES WHERE PATIENTS WERE STAYING LONGER THAN THE EXPECTED APPOINTMENT DURATIONS AS THE MEDICATION DELIVERY WAS TAKING LONGER THAN EXPECTED TO COMPLETE. THE WAS RESIDUAL MEDICATION VOLUME IN THE BAGS THAT WERE NOT DELIVERED TO THE PATIENT DURING THE EXPECTED THERAPY TIME. 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 20251283 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SOLUTION SETS WITH DUO-VENT SPIKE LEAKED TPN (TOTAL PARENTERAL NUTRITION) NEAR THE DRIP CHAMBER. THE LEAK OCCURRED DURING INFUSION HALFWAY THROUGH THE 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 20160396 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET LEAKED FROM UNDER THE DRIP CHAMBER; DROPLETS OF FLUID SLOWLY FORMED DUE TO A SEPARATION OF THE DRIP CHAMBER AND TUBING. THE LEAK WAS OBSERVED DURING SETUP; HOWEVER, PATIENT INVOLVEMENT WAS UNKNOWN. 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 20009879 ↗
• MalfunctionAug 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS FROM FOUR (4) CASES HAD WHITE DISCOLORATION IN THE TUBING ABOVE THE FILTER. THE DISCOLORATION WAS WHITE RESIDUE THAT COULD BE SCRAPED OFF FROM THE INSIDE OF THE TUBING. THIS WAS DISCOVERED UPON RECEIVING THE PRODUCT PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908147 ↗
• MalfunctionJul 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS HAD PARTICULATE MATTER (PM) IN THE TUBING RIGHT ABOVE THE FILTER. THE PM WAS DESCRIBED AS ¿WHITE DISCOLORED SECTION IN THE TUBING RIGHT ABOUT THE FILTER¿ AND ¿WHITE SUBSTANCE CAN BE SCRAPED OFF THE TUBING¿. THE PM 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 19807354 ↗
• MalfunctionApr 15, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET HAD A CRACK AROUND THE BASE OF THE DRIP CHAMBER (HARD, WHITE INTERNAL PIECE); A LEAK WAS OBSERVED COMING FROM THE DRIP CHAMBER. THIS WAS OBSERVED AT THE END OF PATIENT INFUSION WITH TOTAL PARENTERAL NUTRITION (TPN). 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 19111416 ↗
• MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET LEAKED "FROM THE BOTTOM OF THE DRIP CHAMBER" AND "DOWN THE OUTSIDE OF IV TUBING". THIS WAS OBSERVED FEW MINUTES AFTER INFUSION STARTED. THE DEVICE CONTAINED INFLIXIMAB. 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 18855928 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET LEAKED WHERE THE DRIP CHAMBER CONNECTS TO THE LINE; THERE WERE A SMALL AMOUNT OF DROPS ON THE FLOOR. THIS WAS OBSERVED DURING PATIENT USE. A NEW 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 18849889 ↗
• MalfunctionFeb 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET HAD LEAKED AT THE DRIP CHAMBER. THE EVENT OCCURRED WHILE PRIMING THE SET WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691447 ↗
• MalfunctionNov 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SET WAS LEAKING ABOVE THE FILTER. THE LEAK WAS OBSERVED DURING PATIENT INFUSION OF 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 18065079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8