CLEARLINK/DUO-VENT 2C8419Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00085412048956), received between Jan 24, 2018 and Apr 29, 2026 — classified as 3 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K112893); 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-0190-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionApr 3, 2026Blocked Connection; Separation Problem

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO VENT SPIKE TUBING SEPARATED AT THE DISTAL PORT DURING PRIMING WITH A MAGNESIUM SOLUTION. THE REGISTERED NURSE WAS NOT ABLE TO ATTACH THE MALE LUER TO THE PATIENT'S VASCULAR DEVICE, AS THE LEUR COULD NOT BE TWISTED OR ADJUSTED. THE TUBING WAS REMOVED FROM IV BAG AND REPLACED WITH A NEW TUBING SET THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778789 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) SOLUTION SETS WITH DUO-VENT SPIKE SEPARATED WHEN PRIMING THE SETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774911 ↗
• MalfunctionApr 1, 2026Fitting Problem

  IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE COULD NOT BE SECURED, AS THE LUER LOCK MECHANISM WOULD NOT SLIDE DOWN TO THE HUB. THIS OCCURRED DURING IV PLACEMENT PROCEDURE. 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 24760744 ↗
• MalfunctionMar 30, 2026

  RN SPIKED /PRIMED TUBING FOR MAGNESIUM. THE TUBING MALFUNCTIONED. RN WAS NOT ABLE TO ATTACH THE MALE LEUR TO THE PATIENT'S VASCULAR DEVICE. THE LEUR WOULD NOT TWIST OR MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709003 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LOOSE AT THE Y LUER PORT, RESULTING IN THE BOTTOM PART OF THE TUBING DISCONNECTING AND FALLING APART. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558724 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS DETACHED AT THE Y CONNECTION SITE. THIS OCCURRED DURING PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558445 ↗
• MalfunctionMar 5, 2026

  LUER LOCK MECHANISM DID NOT SLIDE DOWN TO THE HUB FOR SECUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518445 ↗
• MalfunctionMar 5, 2026Misconnection

  IT WAS REPORTED THAT THE LUER LOCK MECHANISM OF A CLEARLINK SYSTEM SOLUTION SET DID NOT SLIDE DOWN TO THE HUB FOR SECUREMENT. THIS WAS OBSERVED 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 24514902 ↗
• MalfunctionFeb 18, 2026Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WITH DUO VENT SPIKE LEAKED DURING PATIENT INFUSION THROUGH AN UNSPECIFIED BAXTER INFUSION PUMP. THE DEVICE WAS BEING USED TO ADMINISTER INTRAVENOUS IMMUNOGLOBULIN (IVIG). IT WAS FURTHER NOTED THAT THE FLUSH LUER ACTIVATED VALVE WAS BACK FLOWING AND LEAKING. THE LEAK WAS IDENTIFIED WHEN THE MEDICATION RATE WAS INCREASED AFTER APPROXIMATELY 30 MINUTES. A NEEDLELESS CONNECTOR WAS THEN ATTACHED TO THE VALVE, WHICH STOPPED THE LEAK FOR THE DURATION OF THE MEDICATION ADMINISTRATION. 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 24376831 ↗
• MalfunctionFeb 12, 2026Component Misassembled

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET HAD AN "OPEN VENT" ON THE END WITH NO CAP (CLEARLINK COMPONENT WAS ON THE END INSTEAD OF A MALE LUER). THE ISSUE WAS NOTICED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324774 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SOLUTION SETS BROKE WHEN TRYING TO HANG THE INTRAVENOUS (IV) SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298294 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET WITH DUO VENT SPIKE WAS LEAKING FROM THE PROXIMAL Y SITE. THE ISSUE HAPPENED WHEN THE SECONDARY TUBING WAS CONNECTED TO THE PRIMARY SOLUTION LINE. BLOOD BACKED UP INTO THE TUBING, AND LIQUID BEGAN FLOWING OUT THROUGH THE Y SITE UNEXPECTEDLY. 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 24120481 ↗
• MalfunctionJan 20, 2026Crack; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT LUER LOCK OF THREE (3) CLEARLINK SYSTEM SOLUTION SETS BROKE AND MEDICATION LEAKED; THE OUTER RIM OF THE LUER LOCK WAS CRACKED. THE ISSUE WAS IDENTIFIED DURING CONTINUOUS INFUSION OF PROPOFOL. THE EVENT WAS FURTHER DESCRIBED AS LEAKING "BETWEEN LUER LOCK AT END OF TUBING SET AND THE NEEDLELESS CONNECTOR ON A CENTRAL LINE/THREE WAY STOPCOCK". EACH TIME, THE NURSE FOUND THE TUBING WAS DISCONNECTED FROM AN UNSPECIFIED NEEDLELESS CONNECTOR. WHEN ATTEMPTING TO RECONNECT, THE NURSE WAS UNABLE TO DUE TO THE IDENTIFIED CRACK. 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 24119232 ↗
• MalfunctionJan 15, 2026No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET HAD NO FLOW OF MEDICATION. THIS WAS OBSERVED WHEN ATTEMPTING TO DRAW MEDS FROM A VIAL. 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 24086695 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET SEPARATED FROM THE CLEARLINK PORT AT THE Y-SITE. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879638 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM THE PORT CLOSEST TO THE PATIENT. THIS OCCURRED DURING AMBULATION, WHILE THE PATIENT WAS RECEIVING INTRAVENOUS IMMUNOGLOBULIN (IVIG) THROUGH A CENTRAL LINE. THE LINE WAS CLAMPED, AND THE REMAINING IVIG AND ATTACHED NORMAL SALINE (NS) LINE WERE REMOVED. 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 23865180 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FLUID FROM THE PORT CLOSEST TO THE PATIENT. THIS OCCURRED DURING INTRAVENOUS IMMUNOGLOBULIN (IVIG) ADMINISTRATION. THE LEAK WAS FIRST NOTICED AFTER AMBULATION. 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 23827759 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM A HOLE IN THE DISTAL END OF THE DRIP CHAMBER. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716196 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED A CLEARLINK SYSTEM SOLUTION SET HAD THE TUBING DISCONNECT FROM THE INSERTION LUER CONNECTION (MALE LUER) AND MEDICATION LEAKED ALL OVER THE FLOOR. THE ISSUE WAS OBSERVED APPROXIMATELY 5 MINUTES INTO A PATIENT INFUSION WITH INTRAVENOUS IMMUNOGLOBULIN (IVIG). THE INFUSION WAS STOPPED AND THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. 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 23697496 ↗
• MalfunctionDec 2, 2025Backflow; Backflow

  IT WAS REPORTED THAT AT LEAST THREE (3) CLEARLINK SYSTEM SOLUTION SETS HAD MEDICATION BACK UP INTO THE BAG INSTEAD OF GOING TO THE PATIENT. THIS WAS OBSERVED DURING PATIENT INFUSION WITH SEDATION MEDICATION VIA A PUMP AND/OR INTRAVENOUS PUSH. THE FLOW ISSUE WAS FURTHER DESCRIBED AS "NO FLOW" TO 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 23697205 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM LUER CONNECTOR. THE DEVICE CONTAINED ALBUMIN. 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 23696387 ↗
• InjuryNov 26, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET HAD NO FLOW DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Awareness During Anesthesia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659872 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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