CLEARLINK/CONTINU-FLO/DUO-VENT 2C8541Recalls & reported problems

Summary

The FDA's MAUDE database contains 797 adverse event reports that list this exact device (DI 00085412071107), received between Sep 22, 2017 and Sep 28, 2026 — classified as 15 injuries, 782 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (445 reports).

2 FDA recall records name this device's identifier, 2 still open.

10 other recalls cover devices cleared under the same FDA submission (K203609, K961225); 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.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

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

2. Dec 12, 2019Class IIOpen, 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 problems

Recent adverse event reports

The 25 most recent of 797 reports, 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 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 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 ↗
• MalfunctionJul 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET HAD FLUIDS LEAKING AROUND THE SECTION OF TUBING THAT CONNECTS THE SPIKE/VENT TO THE CHAMBER. THIS OCCURRED 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 25693475 ↗
• MalfunctionJul 1, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD AIR BUBBLES IN THE TUBING. THIS OCCURRED AFTER THE LINES WERE PRIMED AND THE AIR BUBBLES WERE REMOVED. THE FLUID FLOWED WITHOUT BUBBLES INITIALLY; HOWEVER, ONCE THE LINE WAS PLACED INTO THE PUMP, BUBBLES APPEARED FROM THE VALVES. 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 25676824 ↗
• MalfunctionJun 30, 2026

  FOREIGN OBJECT OBSERVED IN IV TUBING (ACTIVELY INFUSING). IV SITE CLAMPED; IV TUBING REMOVED AND IMMEDIATELY REPORTED PER ORGANIZATIONAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664601 ↗
• MalfunctionJun 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED AT THE JUNCTION WHERE THE DRIP CHAMBER CONNECTS TO THE IV TUBING. THE ISSUE WAS IDENTIFIED IN THE RHEUMATOLOGY DEPARTMENT WHEN THE REGISTERED NURSE SPIKED THE BAG MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533680 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET LEAKED FROM A "TEAR" IN THE TUBING. THIS OCCURRED AFTER PRIMING WITH PROPOFOL IN THE ANESTHESIA DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333767 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE LEAKED FROM THE Y-SITE PORT. THIS OCCURRED DURING INFUSION OF INSULIN VIA A NOVUM IQ LVP. THE CLINICIAN IDENTIFIED THE LEAKAGE WHEN THE PATIENT¿S BLOOD GLUCOSE LEVELS INCREASED AND THE BED SHEET WAS OBSERVED TO BE WET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25308650 ↗
• MalfunctionMay 26, 2026Material Puncture/Hole

  IT WAS REPORTED THAT HOLES WERE IDENTIFIED IN TEN (10) CONTINU-FLO SOLUTION SETS WITH DUO-VENT SPIKE. THE EVENT WAS DISCOVERED PRIOR TO PATIENT USE AT THE OR DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285034 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SPONTANEOUSLY DETACHED AT THE MIDPOINT WHILE ACTIVELY INFUSING SALINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219653 ↗
• MalfunctionMay 18, 2026

  LABELING ON THE BACK OF THE BAG IS WORN OFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199741 ↗
• MalfunctionMay 8, 2026Backflow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS NOT INFUSING PROPERLY AND THE PRIMARY BAG (HUNG LOWER) GOT FULLER THAN THE SECONDARY BAG (HUNG HIGHER). THE ISSUE OCCURRED DURING KCL (POTASSIUM CHLORIDE) INFUSION. THE EXPECTED INFUSION TIME WAS 2 HOURS. 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 25125904 ↗
• MalfunctionMay 8, 2026Backflow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS NOT INFUSING PROPERLY AND THE PRIMARY BAG (HUNG LOWER) GOT FULLER THAN THE SECONDARY BAG (HUNG HIGHER). THE ISSUE OCCURRED DURING KCL (POTASSIUM CHLORIDE) INFUSION. THE EXPECTED INFUSION TIME WAS 2 HOURS. 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 25125887 ↗
• InjuryMay 7, 2026Break

  IT WAS REPORTED THAT THE DISTAL MALE LUER CONNECTOR (CLEARLINK) OF A CLEARLINK DUO VENT CONTINU FLO SOLUTION FRACTURED AND BECAME LODGED IN A Y SITE PORT OF ANOTHER PRIMARY TUBING SET. THE EVENT OCCURRED WHILE MULTIPLE VASOPRESSORS WERE BEING ADMINISTERED TO A CRITICALLY ILL PATIENT. AN EMERGENT REPLACEMENT OF BOTH INFUSION LINES WAS PERFORMED, AS THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE DUE TO THE TUBING FAILURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25117261 ↗
• MalfunctionApr 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS MISSING THE BLUE CAP ON THE PATIENT END OF THE TUBING. THE ISSUE WAS IDENTIFIED WHEN THE NURSE WAS PREPARING TO PRIME THE SET, AND THE CAP COULD NOT BE LOCATED IN THE PACKAGING. A NEW TUBING SET WAS OBTAINED, PRIMED, AND USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029075 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE "SNAPPED IN HALF WHILE PRIMING IV FLUIDS". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956867 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, K961225. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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
• Z-0794-2020 · Dec 12, 2019 · Open, Classified
  ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Pro
• Z-0475-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2920-2011 · Jul 21, 2011 · Terminated
  Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-1152-03 · Jul 16, 2003 · Terminated
  Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3 injection sites, Male Luer Lock Adapter, catalog 2C6521; Baxter Healthcare Corporation, Deerf