CLEARLINK/DUO-VENT 2C8875Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00085412046389), received between Jun 10, 2019 and Sep 15, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (30 reports).

8 other recalls cover devices cleared under the same FDA submission (K112893); 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782232 ↗
• MalfunctionAug 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM THE DRIP CHAMBER. THIS OCCURRED DURING CHEMOTHERAPY ADMINSTRATION. 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 17606503 ↗
• MalfunctionMay 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK SYSTEM SOLUTION SET BROKE OFF WHEN SPIKING A DOCETAXEL BAG. THE ISSUE OCCURRED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844996 ↗
• MalfunctionOct 4, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A LOT OF BUBBLES WERE OBSERVED IN THE TUBING OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SOLUTION SETS. THIS RESULTED IN EXTENDING THE ADMINISTRATION TIME. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THE SETS HAD TO BE REPLACED. 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 15539978 ↗
• MalfunctionFeb 10, 2022Material Discolored; Material Discolored

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (APPROXIMATELY 20) CLEARLINK SYSTEM SOLUTION SETS WERE DISCOLORED. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS 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 13506337 ↗
• MalfunctionFeb 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS THE TUBING WAS LEAKING JUST BELOW THE DRIP CHAMBER. THIS ISSUES WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453138 ↗
• MalfunctionJan 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LEAKING BETWEEN THE TUBING AND THE BOTTOM OF THE DRIP CHAMBER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13333816 ↗
• MalfunctionOct 13, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET UNDERINFUSED. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ROUGHLY HALF OF THE VOLUME OF MEDICATION THAT WAS SET TO ADMINISTER. THIS ISSUE WAS IDENTIFIED DURING HYPERBARIC TREATMENT. 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 12622894 ↗
• MalfunctionMar 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) CLEARLINK SYSTEM SOLUTION SETS LEAKED; FURTHER DESCRIBED AS WHEN THE SALINE BAG WAS HUNG, THE WHITE PLASTIC THAT HOLDS THE TUBING LINES TOGETHER IS WHERE IT LEAKED. THE DEVICES WERE USED WITH CHEMOTHERAPY DRUGS ETOPOSIDE AND DOCETAXEL. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489562 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEAR LINK SYSTEM SOLUTION SET WAS LEAKED. DURING A DOCETAXEL (114MG) INFUSION, THE PATIENT OBSERVED FLUID ON THE TUBING. UPON FURTHER EXAMINATION, A "VERY SMALL HOLE" WAS NOTED IN THE TUBING. 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 10825145 ↗
• MalfunctionOct 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DRIPS WERE FORMING ALONG THE WHITE CUFF ON THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET. THIS WAS IDENTIFIED DURING THE ADMINISTRATION OF ETOPOSIDE IN 0.9% SODIUM CHLORIDE 500ML. 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 10687080 ↗
• MalfunctionSep 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SMALL LEAK WAS OBSERVED FROM THE WHITE CONNECTOR OF A CLEARLINK SYSTEM SOLUTION SET. THIS WAS IDENTIFIED DURING PATIENT INFUSION. 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 10606944 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM UNSPECIFIED LOCATION. THIS ISSUE WAS IDENTIFIED DURING CHEMOTHERAPY SESSION. 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 10258745 ↗
• MalfunctionJun 18, 2020Fluid/Blood Leak; Increased Pump Speed; Material Puncture/Hole; Fluid/Blood Leak; Increased Pump Speed; Material Puncture/Hole

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM SOLUTION SETS WERE LEAKING. IT WAS FURTHER REPORTED THAT THE LEAKS WERE FROM PIN SIZE HOLES AT UNSPECIFIED LOCATIONS ON THE SETS. THIS WAS IDENTIFIED DURING USE AT UNSPECIFIED PROCESS STEPS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168642 ↗
• MalfunctionJun 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET LEAKED. IT WAS FURTHER REPORTED THAT "THREE QUARTER SIZED PUDDLES UNDER IV POLE" WAS NOTED. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH ETOPOSIDE. 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 10116597 ↗
• MalfunctionMay 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION WAS LEAKING BENEATH THE LOWER FILTER ON THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET. THIS WAS IDENTIFIED WHILE IN USE FOR A PATIENT INFUSION; FURTHER DESCRIBED AS THE ¿MEDICATION BAG WAS SPIKED AND PRIMED WHEN THE NURSE NOTICED THE TACROLIMUS BEGAN TO DRIP OUT BENEATH THE LOWER FILTER ON THE IV (INTRAVENOUS) TUBING LINE¿. 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 10021928 ↗
• MalfunctionMay 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET LEAKED DURING A TACROLIMUS INFUSION. THE BAG WAS SPIKED TO ADMINISTER THE MEDICATION WHEN THE TUBING WAS NOTED TO BE LEAKING. A NEW SET WAS USED TO COMPLETE THERAPY. 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 10017565 ↗
• MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE WHITE UPPER SECTION OF THE TUBING. THE LEAK WAS OBSERVED AFTER PRIMING THE TUBING 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 10007619 ↗
• MalfunctionApr 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CLEARKLINK SOLUTION SETS "LEAKED AROUND THE WHITE CONNECTOR PLACED IN THE LINE OF THE TUBING". THIS ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEP 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 Patient Involvement

  MAUDE report 9998872 ↗
• MalfunctionApr 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM THE WHITE CRIMPS OF THE TUBING. THIS ISSUE WAS IDENTIFIED DURING CYTARABINE INTRAVENOUS INFUSION TO A PATIENT. 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 9983929 ↗
• MalfunctionApr 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED AT THE WHITE CRIMPS OF THE TUBING. THIS ISSUE WAS IDENTIFIED DURING CYCLOPHOSPHAMIDE INTRAVENOUS PIGGYBACK (IVPB) TO A PATIENT. THE INFUSION WAS STOPPED AND THE SET REPLACED; THE NURSE WAS ABLE TO COMPLETE THE INFUSION WITHOUT FURTHER ISSUES. 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 9977794 ↗
• MalfunctionMar 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SOLUTION SETS WERE DISCOVERED TO HAVE CUT TUBING WHICH RESULTED IN LEAKAGE OF SOLUTION. DURING AN UNSPECIFIED PROCESS STEP, THE CUSTOMER OBSERVED THAT THERE WAS A FRACTURE IN THE LINE WHICH RESULTED IN LEAKAGE OF ETOPOSIDE CHEMOTHERAPY. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. 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 9905540 ↗
• MalfunctionMar 31, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET HAD A FRACTURE IN THE LINE WHICH LEAD TO A LEAK OF A CHEMOTHERAPY MEDICATION; THIS WAS FURTHER DESCRIBED AS THE DEVICE ¿LEAKED AT THE PUMPING TUBING SEGMENT.¿ THIS ISSUE WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 9903327 ↗
• MalfunctionMar 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SOLUTION SETS WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAKS WERE 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 Consequences Or Impact To Patient

  MAUDE report 9900767 ↗
• MalfunctionMar 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET WAS LEAKED AT THE WHITE JUNCTION. THIS WAS IDENTIFIED DURING PATIENT INFUSION OF UNSPECIFIED "ANTI-REJECT" DRUG. 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 9898150 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112893. One submission often covers many models, so check the product and lot details in each record.

• Z-0197-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
• Z-0190-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
• Z-0199-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
• Z-0191-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
• Z-0198-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
• Z-1653-2022 · Aug 9, 2022 · Terminated
  Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
• Z-0099-2014 · Sep 4, 2013 · Terminated
  Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
• Z-1271-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte