CLEARLINK/DUO-VENTRecalls & reported problems across all models

We found 5 models of CLEARLINK/DUO-VENT by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 282 adverse event reports in the FDA's MAUDE database, received between Jan 24, 2018 and Sep 22, 2026 — classified as 4 injuries, 278 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (162 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CLEARLINK/DUO-VENT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0190-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported CLEARLINK/DUO-VENT problems

CLEARLINK/DUO-VENT models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CLEARLINK/DUO-VENT 2C8419

  Set, administration, intravascular
  1 recall105 reports
• CLEARLINK/DUO-VENT 2C7462

  Set, administration, intravascular
  57 reports
• CLEARLINK/DUO-VENT 2R8875

  Set, administration, intravascular
  51 reports
• CLEARLINK/DUO-VENT 2C8875

  Set, administration, intravascular
  37 reports
• CLEARLINK/DUO-VENT 2H8480

  Set, administration, intravascular
  32 reports

Recent CLEARLINK/DUO-VENT adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 15, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782232 ↗
• MalfunctionSep 7, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650950 ↗
• MalfunctionAug 26, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460760 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459564 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409941 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165426 ↗
• MalfunctionJun 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD HAIR OR FIBER INSIDE CHAMBER, HALF COMPRESSED INTO ATTACHMENT POINT AND THE PARTICULATE MATTER WAS LOCATED INSIDE THE FLUID PATH. THE ISSUE 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 25353262 ↗
• 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 29, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE LEAKED DUE TO A CUT/SLICE IN THE SOFT TUBING. THIS WAS OBSERVED A FEW MINUTES AFTER STARTING A SALINE 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 25034249 ↗
• MalfunctionApr 28, 2026Fitting Problem

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE MALE LUER WAS NOT ATTACHING TO THE PATIENT'S VASCULAR DEVICE. THE LUER WOULD NOT TWIST OR MOVE. THE EVENT OCCURRED DURING MAGNESIUM 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 25020737 ↗
• 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 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 ↗
• MalfunctionApr 10, 2026Disconnection; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE LEAKED DURING AN IMMUNOGLOBULIN INFUSION. A DISCONNECTION WAS OBSERVED BETWEEN THE TUBING AND THE LUER LOCK. 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 24845170 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls