CLEARLINK/DUO-VENT 2C8851Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00085412046365), received between Dec 14, 2018 and Apr 14, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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, 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 30 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED AT THE VENT CAP NEAR THE DRIP CHAMBER. THIS WAS OBSERVED DURING INFUSION. THE DEVICE CONTAINED DOCETAXEL. 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 23075186 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM NITROGLYCERIN SETS LEAKED FROM THE DRIP CHAMBER. 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 22065045 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NITROGLYCERIN SETS LEAKED FROM 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 22063867 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED FROM THE TUBING SHAFT CLOSE TO THE FLUID CHAMBER. THIS WAS OBSERVED WHEN THE SECOND BOTTLE OF IVIG (INTRAVENOUS IMMUNOGLOBULIN) WAS INITIATED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778888 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED FROM UNSPECIFIED LOCATION. THIS OCCURRED WHILE PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548509 ↗
• MalfunctionFeb 26, 2024Backflow; Air/Gas in Device; Backflow; Air/Gas in Device

  IT WAS REPORTED THAT BLOOD BACKED UP INTO THE TUBING OF AN UNSPECIFIED QUANTITY (AT LEAST TWO) OF CLEARLINK SYSTEM NITROGLYCERIN SETS. THE PUMP REGISTERED THAT THERE WAS AIR IN THE TUBING. THIS OCCURRED DURING PATIENT INFUSION. THE TUBING WAS DISCONNECTED FROM THE PATIENT TO TROUBLE SHOOT THE PROBLEM, BUT THE AIR WOULD AGAIN BACK UP INTO THE MEDICATION BOTTLE. 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 18784371 ↗
• MalfunctionJan 11, 2024

  OUR NITROGLYCERIN TUBING DID NOT PRIME APPROPRIATELY TO GRAVITY WHEN ADMINISTERING ALBUMIN. WE WERE REQUIRED TO PRIME IT USING THE SIGMA PUMP WHICH TOOK MORE TIME AND IS NOT OUR TYPICAL PRACTICE ULTIMATELY DELAYING THE ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490993 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NITROGLYCERIN SETS HAD LARGE AMOUNTS OF AIR BUBBLES IN THE TUBING AND LEAKED FLUID FROM THE DRIP CHAMBER. THIS WAS DISCOVERED WHILE PRIMING TOTAL PARENTERAL NUTRITION (TPN). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854734 ↗
• MalfunctionAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED FROM THE LINE. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED CHEMOTHERAPY DRUG. THE LEAK SPILLED ONTO THE FLOOR AND INTRAVENOUS (IV) PUMP. THE NURSE WAS EXPOSED TO THE CHEMOTHERAPY DRUG; HOWEVER, THE NURSE WASHED THEIR HAND WITH SOAP AND WARM WATER. 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 17568753 ↗
• MalfunctionAug 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED. THE ISSUE OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552759 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET WAS LEAKING FROM THE BASE OF THE CHAMBER. THIS WAS DISCOVERED DURING USE OF THE DEVICE, WHILE THE PATIENT WAS CONNECTED. 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 17343234 ↗
• MalfunctionJul 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS WERE LEAKING AROUND ONE OF THE WHITE CONNECTOR SLEEVES ON THE SETS. IT WAS ALSO REPORTED THAT THE SETS WERE LEAKING AROUND THE WHITE CONNECTORS (BUSHINGS) WHICH CONNECT THE POLYETHYLENE LINED TUNING TO THE PUMPING SEGMENT. THIS WAS DISCOVERED DURING PREPARATION OF MEDICATION, PRIOR TO BEING DISPENSED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321270 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS WERE LEAKING. THE LOCATION OF THE LEAK WAS DESCRIBED AS, ¿FROM AROUND THE PRIMING CHAMBER AND WHERE THE LINE CONNECTS TO IT THE LINE ITSELF¿. THIS WAS DISCOVERED DURING COMPOUNDING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299328 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS WERE LEAKING. THE LOCATION OF THE LEAK WAS DESCRIBED AS, ¿FROM AROUND THE PRIMING CHAMBER AND WHERE THE LINE CONNECTS TO IT THE LINE ITSELF¿. THIS WAS DISCOVERED DURING COMPOUNDING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299297 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET WAS LEAKING AROUND THE PRIMING CHAMBER WHERE THE LINE CONNECTED. THIS WAS OBSERVED 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 17298413 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET WAS LEAKING AROUND THE PRIMING CHAMBER WHERE THE LINE CONNECTED. THIS WAS OBSERVED 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 17298319 ↗
• MalfunctionJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED AROUND THE PRIMING CHAMBER WHERE THE LINE WAS CONNECTED. THE ISSUE WAS OBSERVED IN THE PHARMACY ROOM BEFORE THE PRODUCT WAS DISPENSED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283180 ↗
• MalfunctionJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS LEAKED AROUND THE PRIMING CHAMBER WHERE THE LINE WAS CONNECTED. THE ISSUE OCCURRED DURING AN UNKNOWN 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 17281478 ↗
• MalfunctionJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS LEAKED AROUND THE PRIMING CHAMBER WHERE THE LINE WAS CONNECTED. THE ISSUE OCCURRED DURING AN UNKNOWN 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 17281338 ↗
• MalfunctionApr 6, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET HAD AIR IN THE DRIP CHAMBER. THIS WAS DISCOVERED DURING PATIENT USE. THE SET WAS CHANGED 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 16692669 ↗
• MalfunctionApr 6, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NITROGLYCERIN SET HAD AIR IN THE DRIP CHAMBER. 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 16690569 ↗
• MalfunctionJan 13, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP DISPLAYED A ¿DOWNSTREAM OCCLUSION¿ ALARM WHILE BEING USED WITH UNKNOWN QUANTITY OF CLEARLINK SYSTEM NITROGLYCERIN SETS. THIS WAS OBSERVED UPON INITIATING 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 16161826 ↗
• MalfunctionMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM NITROGLYCERIN SETS LEAKED AT THE HOB SITE OF THE TUBING. THE ISSUE WAS IDENTIFIED 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 13951811 ↗
• MalfunctionMar 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NITROGLYCERIN SET LEAKED AT THE BOTTOM OF THE FILL DRIP CHAMBER WHERE THE POLYVINYL CHLORIDE (PVC) LINE WAS CONNECTED. THE ISSUE WAS IDENTIFIED DURING PATIENT ADMINISTRATION OF CARMUSTINE. 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 13794356 ↗