CLEARLINK/DUO-VENT 2H8480Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00085412048499), received between Mar 9, 2018 and Aug 6, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165426 ↗
• MalfunctionApr 23, 2026Crack

  DURING EVALUATION OF A RETURNED CLEARLINK SYSTEM NON DEHP SOLUTION SET WITH DUO-VENT SPIKE, THE FILTER INSIDE THE MICRON FILTER COMPONENT WAS FOUND TO BE RUPTURED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967792 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET WITH DUO-VENT SPIKE LEAKED AFTER INFLIXIMAB INFUSION. DURING SETUP, AIR BUBBLES WERE NOTED IN THE DISTAL PORTION OF THE TUBING; THE SET WAS NOT CONNECTED TO THE PATIENT, AND THE LINE WAS PRIMED TO REMOVE THE AIR. AFTER THE INFUSION WAS COMPLETED, THE SET WAS DISCONNECTED FROM THE PATIENT AND CLAMPED WITH BOTH THE ROLLER CLAMP AND THE PUMP. DESPITE THIS, THE LINE BEGAN LEAKING SOLUTION ONTO THE FLOOR. 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 24769607 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT 8 TO 10 UNITS OF CLEARLINK SYSTEM NON DEHP SOLUTION SETS LEAKED AT THE LUER CONNECTORS. THE ISSUE OCCURRED AFTER THE LINE WAS CONNECTED TO THE NON-BAXTER ANGIO SYSTEM, WHERE LEAKAGE WAS OBSERVED FROM CONNECTOR AREA #9 AND THE LUER CONNECTOR (#8), WITH FLUID LEAKING FROM BOTH THE CONNECTION INTERFACE AND THE LUER CONNECTOR WHILE THE PRODUCT WAS IN USE ON A PATIENT AND OPERATED WITH AN INFUSION 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 24303878 ↗
• MalfunctionJan 15, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED TPN (TOTAL PARENTERAL NUTRITION) FROM THE HUB OF THE Y CONNECTION. THE AMINO ACID LINE WAS DISCONNECTED. THIS 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 24087579 ↗
• MalfunctionJan 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT FIFTEEN (15) CLEARLINK SYSTEM NON DEHP SOLUTION SETS LEAKED AT THE JUNCTION WITH THE CATHETER. 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 24026596 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED WHEN THE SPIKE FELL OUT OF THE BAG. THE DEVICE CONTAINED TPN (TOTAL PARENTERAL NUTRITION) AND LIPIDS. 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 22889995 ↗
• MalfunctionMay 30, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE OF TWO (02) CLEARLINK SYSTEM NON-DEHP SOLUTION SETS DISLODGED FROM UNSPECIFIED TOTAL PARENTERAL NUTRITION (TPN) BAGS, RESULTING IN SOME OF THE TPN SPILLING ONTO THE FLOOR. THIS OCCURRED DURING PATIENT INFUSION. THE TUBING SPIKES "SEEM TO NOT FIT WELL INTO THE BAGS OF TPN AS THEY BECOME DISLODGED VERY EASILY". 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 22114851 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Protective Measures Problem; Air/Gas in Device; Detachment of Device or Device Component; Protective Measures Problem; Air/Gas in Device

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON DEHP SOLUTION SETS HAD DEFECTS PREVENTING PRIMING OF THE DEVICES. ONE (1) SET HAD CONSTANT AIR BUBBLES WHICH RESULTED IN AN OCCLUSION ALARM ON AN UNSPECIFIED PUMP DURING PRIMING WITH AMINO ACIDS. WHILE THE FILTER WAS INSPECTED, A GAP WAS NOTICED AT THE AREA PROXIMAL TO THE BAG; FURTHER DESCRIBED AS "WHEN LOOKING AT OTHER TUBING THIS AREA TO FILTER LOOKS DIFFERENT" AND "IT SOUNDS LIKE AIR ESCAPING" WHEN A SYRINGE WAS USED TO PUSH AND PULL. ANOTHER FILTER WAS PULLED WHICH APPEARED TO HAVE THE SAME DEFECT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027756 ↗
• MalfunctionJul 12, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK SYSTEM NON DEHP SOLUTION SET CAME OUT OF AN UNSPECIFIED TOTAL PARENTERAL NUTRITION (TPN) AMINO ACID BAG RESULTING IN A SPILL. THIS WAS IDENTIFIED 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 17307064 ↗
• MalfunctionMay 31, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE OF TWO (2) CLEARLINK SYSTEM NON DEHP SOLUTION SETS FELL OUT OF UNSPECIFIED TOTAL PARENTERAL NUTRITION (TPN) BAGS; TPN LEAKED ON THE FLOOR. THIS WAS IDENTIFIED WHEN REVIEWING THE PATIENT LABEL FOR 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 17035269 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED WITH AN UNSPECIFIED CHEMOTHERAPY PRODUCT. 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 15396298 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED WITH AN UNSPECIFIED CHEMOTHERAPY PRODUCT. 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 15395734 ↗
• MalfunctionAug 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET WAS CONNECTED TO AN UNSPECIFIED INFUSION PUMP AND THE SET BEGAN TO LEAK AT THE JUNCTION BETWEEN THE DRIP CHAMBER AND PROXIMAL TUBING (TUBING BELOW THE DRIP CHAMBER). THIS WAS OBSERVED DURING PATIENT INFUSION, AFTER AMINO ACIDS WERE PRIMED. THE TUBING SET WAS DISCONNECTED FROM THE PATIENT. 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 15200871 ↗
• MalfunctionMay 4, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT A DISCONNECTION OCCURRED WHILE USING A CLEARLINK SYSTEM NON DEHP SOLUTION SET. THE DISCONNECTION WAS FURTHER DESCRIBED AS, ¿TOTAL PARENTERAL NUTRITION (TPN) LINE HAD DISCONNECTED WHERE TUBING ENTERS THE INLINE FILTER¿. THIS ISSUE WAS IDENTIFIED 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 14281856 ↗
• MalfunctionOct 25, 2021Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR IN THE FILTER OF A CLEARLINK SYSTEM NON DEHP SOLUTION SET. IT WAS FURTHER STATED THAT AS THE FILTER BECAME FULL OF AIR, FLUID DRIPPED OUT THE END DESPITE ALL CLAMPS BEING CLOSED. THIS ISSUE WAS IDENTIFIED WHILE PRIMING THE TUBING FOR TOTAL PARENTAL NUTRITION (TPN). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693666 ↗
• MalfunctionOct 7, 2021Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED AIR WAS OBSERVED IN THE FILTER OF A CLEARLINK SYSTEM NON DEHP SOLUTION SET. THE EVENT WAS FURTHER REPORTED AS "THE FILTER KEPT FILLING WITH AIR EVEN WITH ALL CLAMPS CLOSED". THE DEVICE WAS FILLED WITH PARENTERAL NUTRITION. THE SET HAD TO E REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12592524 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED. IT WAS STATED THAT WHEN ASSESSING THE PATIENT, SOME STICKY LIQUID WAS OBSERVED/FELT IN THE BED NEAR THE INTRAVENOUS (IV) LINES. WHEN TRACING THE LINES A FEW MINUTES LATER, THE FILTER PORTION OF THE TPN LINE WAS OBSERVED LEAKING. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463597 ↗
• MalfunctionMar 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED ABOVE THE FILTER. THE LEAK WAS OBSERVED ONCE THE LINE WAS PRIMED WITH UNSPECIFIED SOLUTION. THE SET WAS USED WITH TOTAL PARENTAL NUTRITION BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575372 ↗
• MalfunctionFeb 19, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE OF CLEARLINK SYSTEM NON DEHP SOLUTION SET SLIPPED OUT HALF WAY FROM THE 1000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WHICH RESULTED IN A LEAK. THIS WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349307 ↗
• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF FOUR (4) CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS WERE LEAKING WITH THE CLAMP CLOSED. IT WAS FURTHER REPORTED THAT ON CLOSER INSPECTION LEAKING WAS FOUND JUST ABOVE THE FILTER. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10629454 ↗
• MalfunctionAug 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS THE LEAK OCCURRED ¿WHILE PRIMING, BEFORE ANY PATIENT CONNECTION, AND BEFORE BEING HOOKED UP TO THE SIGMA PUMP¿. THE DEVICE ¿HAD A VALVE LEAK AND TO TRY TO STOP IT THEY PUT THE¿ NON-BAXTER CAP ON; HOWEVER, ¿IT CONTINUED TO LEAK¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10436645 ↗
• MalfunctionApr 20, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON DEHP SOLUTION SET BROKE BY THE BLUE CLAMP WHICH CAUSED A LEAK OF INTRAVENOUS (IV) SOLUTION. THIS WAS IDENTIFIED WHEN THE SET WAS BEING PLACED INTO AN UNSPECIFIED PUMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978364 ↗
• MalfunctionMar 17, 2020Disconnection; Disconnection

  IT WAS REPORTED THE CLEARLINK SYSTEM NON DEHP SOLUTION SET DISCONNECTED. THE EVENT WAS FURTHER DESCRIBED AS "WITH IV TUBING DISCONNECTED FROM PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE EXTENSION TUBING". IT "APPEARS THE END OF THE IV SOLUTION SET HAD POPPED OF THE CAP OF THE EXTENSION Y-SET ATTACHED TO PICC LINE CAP". THIS WAS IDENTIFIED DURING PATIENT INFUSION OF AMINO ACIDS 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 Consequences Or Impact To Patient

  MAUDE report 9838501 ↗
• MalfunctionJan 30, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET WAS DEFECTIVE. IT WAS FURTHER REPORTED THAT WHEN THE ROLLER CLAMP WAS CLOSED THE FILTER CONTINUED TO EMPTY AND DRIP FLUID. THIS WAS IDENTIFIED DURING PRIMING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9648600 ↗

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-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
• 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