CLEARLINK/CONTINU-FLO/DUO-VENTRecalls & reported problems across all models

We found 3 models of CLEARLINK/CONTINU-FLO/DUO-VENT by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 873 adverse event reports in the FDA's MAUDE database, received between Sep 22, 2017 and Sep 28, 2026 — classified as 17 injuries, 856 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (494 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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/CONTINU-FLO/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, 2025Open, Classified

   IV sets may leak.

   Z-0194-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Dec 20, 2024Open, Classified

   Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

   Z-1010-2025 · Root cause: Process control · Recall details · FDA record ↗

3. Dec 12, 2019Open, Classified

   Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

   Z-0793-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported CLEARLINK/CONTINU-FLO/DUO-VENT problems

CLEARLINK/CONTINU-FLO/DUO-VENT models

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

• CLEARLINK/CONTINU-FLO/DUO-VENT 2C8541

  Set, administration, intravascular
  2 recalls797 reports
• CLEARLINK/CONTINU-FLO/DUO-VENT 2R8538

  Set, Administration, Intravascular
  1 recall70 reports
• CLEARLINK/CONTINU-FLO/DUO-VENT ALT2403

  Set, administration, intravascular
  6 reports

Recent CLEARLINK/CONTINU-FLO/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 28, 2026No Flow

  It was reported that an Extension Set did not allow fluid to flow by gravity after connection to the patient. Resistance was encountered when attempting to flush fluid through the tubing and catheter. The intravenous catheter was restarted, resulting in more than one intravenous stick. When the tubing was replaced, flow returned to normal. 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 50918915 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918644 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that a CLEARLINK System CONTINU-FLO Solution Set leaked at the connection between the spike and drip chamber while chemotherapy remained in the tubing. This occurred during an unspecified process step while the set was connected 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 50850032 ↗
• MalfunctionSep 17, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811881 ↗
• MalfunctionSep 15, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780037 ↗
• MalfunctionSep 14, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756617 ↗
• MalfunctionSep 12, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50744863 ↗
• MalfunctionSep 9, 2026Break; Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50694295 ↗
• MalfunctionAug 21, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380332 ↗
• MalfunctionAug 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287214 ↗
• MalfunctionAug 13, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241125 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239958 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  It was reported that a CLEARLINK System Solution Set with DUO-VENT Spike leaked at the blue vent. The issue was identified after priming with Normal Saline (NS). The process step at which the issue occurred was not specified. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201845 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165713 ↗
• InjuryJul 31, 2026Detachment of Device or Device Component

  It was reported that a CONTINU-FLO Solution Set with DUO-VENT Spike separated at an unspecified location during a Levophed infusion. The issue was identified when the patient¿s blood pressure monitoring indicated a decrease in blood pressure. As a result, a new infusion setup was initiated. No additional information is available.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50094078 ↗

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
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls