CLEARLINK/CONTINU-FLO/DUO-VENT ALT2403Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00197886004359), received between Aug 20, 2024 and Sep 2, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K203609, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A QUICKSTAY SET WAS SEPARATED FROM THE LUER LOCK MECHANISM. THE ISSUE WAS FURTHER DESCRIBED AS, THE SET WAS SECURED BY ENSURING THE LUER LOCK WAS PROPERLY ATTACHED TO THE INTRAVENOUS (IV) CATHETER AND TAPED DOWN ON THE PATIENT'S HAND. UPON INSPECTION, WATER WAS OBSERVED ON THE FLOOR NEXT TO THE STRETCHER. THE TUBING HAD COME APART FROM THE "LEUR LOCK" MECHANISM OF THE IV TUBING ITSELF. THIS OCCURRED DURING PATIENT INFUSION. THE ISSUE WAS RESOLVED BY REPLACING THE SET WITH A NEW ONE. 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 22934996 ↗
• MalfunctionJun 17, 2025Disconnection; Disconnection

  IT WAS REPORTED TWO (2) CLEARLINK/CONTINU-FLO SETS DISCONNECTED AND LEAKED. DURING UNSPECIFIED SURGICAL PROCEDURES (ALSO REPORTED AS ENDOSCOPY AND UNSPECIFIED SURGICAL PROCEDURES REQUIRING SEDATION/GENERAL ANESTHESIA), THE SETS DISCONNECTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236734 ↗
• InjuryJun 17, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK/CONTINU-FLO SET DISCONNECTED AND LEAKED. DURING AN UNSPECIFIED SURGICAL PROCEDURE (ALSO REPORTED AS ENDOSCOPY AND UNSPECIFIED SURGICAL PROCEDURES REQUIRING SEDATION/GENERAL ANESTHESIA), THE PATIENT WOKE DURING THE SURGERY WHICH REQUIRED THE MEDICAL TEAM TO ADMINISTER ¿MORE ANESTHESIA VIA IV.¿ UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT THERE WAS A LEAK AT THE IV CONNECTION: SPECIFICALLY, BETWEEN THE HAND AND THE IV TUBING. THE SOLUTION HAD POOLED ON THE FLOOR. THE ¿CONNECTION APPEARED TO BE UNDONE¿ LEADING TO PROPOFOL LEAKAGE. NO BLOOD LOSS OCCURRED. THE LEAK WAS IDENTIFIED DURING THE PROCEDURE WHEN THE PATIENT REGAINED CONSCIOUSNESS. THE DURATION OF PROPOFOL THERAPY WAS MORE THAN 20 MINUTES. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Awareness During Anesthesia

  MAUDE report 22236733 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF QUICKSTAY SETS HAD AIR BUBBLES AND LEAKS AFTER CONNECTION WITH THE INTRAVENOUS (IV) CATHETER. THESE OCCURRED DURING UNSPECIFIED PROCESS STEPS. 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 21396202 ↗
• MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE TUBING OF AN UNSPECIFIED QUANTITY OF QUICKSTAY CLEARLINK SYSTEM CONTINU-FLOW SOLUTION SETS APPEARED KINKED. THE EVENT 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 20015784 ↗
• MalfunctionAug 20, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE SLIDER CLAP OF AN UNSPECIFIED QUANTITY OF QUICKSTAY CLEARLINK SYSTEM CONTINU-FLOW SOLUTION SETS DID NOT SPRING BACK TO THE ORIGINAL FORM. IT WAS NOT REPORTED IF THERE WAS AN OVER INFUSION DUE TO THE CLAMP. THE EVENT 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 20002162 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, 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-0194-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0193-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0192-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
• Z-2594-2025 · Aug 8, 2025 · Open, Classified
  Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration s
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519