CLEARLINK/DUO-VENT 2R8875Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00085412565637), received between Jun 25, 2019 and Sep 22, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (40 reports).

15 other recalls cover devices cleared under the same FDA submission (K112893, K180739, K243529); 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026No Flow

  It was reported that a Solution Set with DUO-VENT Spike exhibited no flow, resulting in under infusion of cyclosporine. The reporter stated that the infusion was attempted using three different Baxter infusion pumps, and all three pumps generated downstream occlusion alarms when administration of the medication was attempted. The bedside nurse disconnected the tubing from the patient¿s central line and confirmed that the central line flushed without difficulty. The administration set was removed from the pump, all clamps were opened, and the cap was removed; however, no cyclosporine was observed dripping from the tubing. A syringe was used in an attempt to withdraw cyclosporine from the distal port of the tubing without success. The dose was reordered and the original dose was wasted, resulting in a delay of therapy of greater than two hours. The reporter stated that the patient did not receive the full prescribed dose. 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 50855760 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409941 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) SOLUTION SETS WITH DUO-VENT SPIKE LEAKED SALINE SOLUTION AT THE WHITE CONNECTION (TUBING BUSHING) UNDER THE DRIP CHAMBER. THIS OCCURRED WHILE A NURSE WAS HANGING THE CHEMOTHERAPY BAGS CONTAINING PACLITAXEL, AFTER THE SETS WERE PRIMED WITH SALINE. 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 25186244 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WITH DUO-VENT SPIKE DETACHED AT THE WHITE CONNECTOR RESULTING IN A LEAK. THIS WAS OBSERVED WHEN PRIMING WITH ABRAXANE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165255 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED DURING PRIMING. THE REPORTER STATED THAT WHEN THE PHARMACIST ¿PUT SALINE INTO THE TUBING, IT SPRAYED OUT LIKE THERE WAS A HOLE IN IT¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901258 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SOLUTION SET WITH DUO-VENT SPIKE SEPARATED FROM THE JUNCTION WITH THE WHITE PIECE WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED WHILE PREPARING THE PRODUCT WITH ARSENIC PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501254 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM BETWEEN THE TUBING AND THE ¿WHITE HUB¿. THE LEAK WAS OBSERVED DURING PATIENT INFUSION WITH CHEMOTHERAPEUTIC AGENT (OXALIPLATIN). 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 24471572 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED DUE TO A FAULTY WHITE CONNECTION PIECE. THE LEAKAGE WAS ENTIRELY CONTAINED IN THE TRASH CAN BELOW THE PUMP. THIS OCCURRED DURING PATIENT INFUSION WITH AN UNSPECIFIED CHEMOTHERAPY AGENT. 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 24461367 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET FAILED AT THE WHITE CONNECTION PIECE IN MIDDLE OF THE SET WHICH RESULTED IN LEAK OF INTRAVENOUS (IV) FLUID. THE ISSUE OCCURRED DURING STERILE COMPOUNDING PRIOR TO ADDITION OF DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390178 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET FAILED AT THE WHITE CONNECTION PIECE IN MIDDLE OF THE SET (BUSHING) WHICH RESULTED IN LEAK OF INTRAVENOUS (IV) FLUID. THE ISSUE OCCURRED DURING STERILE COMPOUNDING IN THE PHARMACY PRIOR TO ADDITION OF DRUG. THE SET WAS ATTACHED TO A BAG AND THE TUBING WAS PRIMED WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389881 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM, SOLUTION SET LEAKED AT THE CONNECTION BETWEEN THE WHITE HUB AND TUBING. THIS OCCURRED 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 24144786 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED AT THE CONNECTION BETWEEN THE WHITE HUB AND TUBING. THIS OCCURRED 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 24140007 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM THE JOINT/JUNCTION (THE WHITE PIECE OF CONNECTING TUBING BETWEEN SOFTER AND MORE RIDGED TUBING). THE LEAK WAS OBSERVED PRIOR TO ADMINISTRATION TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883142 ↗
• MalfunctionDec 5, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE WRITING ON THE PRIMARY PACKAGE LABEL OF UNSPECIFIED UNITS OF CLEARLINK SYSTEM, SOLUTION SETS WAS SMEARING. THIS OCCURRED WHILE THE PRODUCTS WERE WIPED WITH ISOPROPYL ALCOHOL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725647 ↗
• MalfunctionJul 3, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF SOLUTION SETS HAD TINY BUBBLES TRIGGERING AIR ALARMS ON SIGMA SPECTRUM INFUSION PUMPS. THIS WAS OBSERVED DURING PATIENT INFUSIONS WITH PACLITAXEL AND 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 22398571 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED FROM THE PORT OF THE TUBING NEAR THE PATIENT. THIS WAS OBSERVED DURING MEDICATION FLUSH OF A TACROLIMUS IV (INTRAVENOUS) 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 22358685 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM ONE OF THE RUBBER PIECES ATTACHED TO THE TUBING. THIS OCCURRED WHILE PRIMING THE LINE WITH NORMAL SALINE IN PREPARATION FOR A CHEMOTHERAPY PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559031 ↗
• MalfunctionOct 28, 2024No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A CLEARLINK SYSTEM, SOLUTION SET. THIS WAS OBSERVED WHILE PRIMING THE INTRAVENOUS (IV) 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 20551473 ↗
• MalfunctionOct 28, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET WOULD NOT CONNECT TO A NON-BAXTER CONNECTOR. THIS ISSUE WAS IDENTIFIED IN A HOSPITAL SETTING 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 20547235 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED FROM THE JUNCTION OF THE TUBING AND DRIP CHAMBER. THIS OCCURRED WHILE PRIMING THE SET WITH NORMAL SALINE FOR A CHEMOTHERAPY PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020081 ↗
• MalfunctionJul 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE FILTER. THE LEAK WAS DESCRIBED AS A SMALL CHEMOTHERAPY LEAK COMING FROM THE FILTER 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 19750555 ↗
• MalfunctionJun 12, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET WITH DUO-VENT SPIKE WOULD NOT CONNECT WHEN TRYING TO ATTACH A NON-BAXTER CAP. THE SET WAS PRIMED WITH AN UNSPECIFIED HAZARDOUS DRUG. 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 19520256 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM, SOLUTION SET LEAKED. AFTER THE SET WAS SPIKED AND PRIMED, A LEAK WAS NOTED, AND IT APPEARED TO ORIGINATE FROM THE WHITE CONNECTOR AROUND THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989598 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED CHEMOTHERAPY DUE TO A HOLE IN THE TUBING. THIS WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17916508 ↗
• MalfunctionSep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, SOLUTION SET LEAKED; THE NURSE FELT A SMALL DROP OF "SOMETHING" HIT THEIR ARM WHEN HANGING CYCLOPHOSPHAMIDE. THE ISSUE WAS IDENTIFIED DURING PATIENT USE, AT BESIDE IN THE HOSPITAL. THE NURSE RE-INSPECTED THE SET AND NOTED A SMALL DRIP FORMED AT THE CONNECTION POINT OF THE TUBING THAT GOES INTO THE PUMP AND THE PART THAT GOES TO 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 17818709 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112893, K180739, K243529. One submission often covers many models, so check the product and lot details in each record.

• Z-2766-2026 · Jun 30, 2026 · Open, Classified
  Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
• 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-0202-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
• 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-0201-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
• 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-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-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-0203-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-i
• Z-1010-2025 · Dec 20, 2024 · Open, Classified
  Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
• Z-1009-2025 · Dec 20, 2024 · Open, Classified
  Baxter Solution Set with Duo-Vent Spike, REF 2R8404
• Z-1291-2024 · Feb 8, 2024 · Open, Classified
  CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
• 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