CLEARLINK 2N8399Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00085412048895), received between Mar 23, 2018 and Apr 29, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 reports).

8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVES DISCONNECTED DURING IMAGING SCANS. THERE WERE ATTEMPTS TO TIGHTEN THE CONNECTIONS MULTIPLE TIMES WITHOUT SUCCESS. AS A RESULT, THE DEVICES WERE DISCONNECTED AND NEW EXTENSIONS CONNECTED TO CONTINUE THE PROCEDURES. 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 25034616 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE TO IV ACCESS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED 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 23478677 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE LEAKED CHEMO FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING PATIENT USE. 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 23439561 ↗
• MalfunctionAug 23, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVES DISCONNECTED FROM SYRINGES FILLED WITH RHO(D) IMMUNE GLOBULIN. THE DISCONNECTIONS OCCURRED DURING PATIENT ADMINISTRATION VIA AN INTRAVENOUS (IV) PUSH. WHEN THE NURSE PUSHED ON THE SYRINGES, THE VALVES WOULD TWIST AND FALL OFF. 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 20047874 ↗
• MalfunctionAug 22, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE DISCONNECTED FROM A SYRINGE FILLED WITH RHO(D) IMMUNE GLOBULIN. THE DISCONNECTION OCCURRED DURING PATIENT ADMINISTRATION VIA AN INTRAVENOUS (IV) PUSH. WHEN THE NURSE PUSHED ON THE SYRINGE, THE VALVE TWISTED AND FELL OFF. THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, THE MEDICATION WAS GIVEN INTRAMUSCULARLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031605 ↗
• MalfunctionAug 20, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE HAD A CRACK WHICH RESULTED IN LEAK; FURTHER DESCRIBED AS "BLOWING OUT UNDER PRESSURE INJECTION". THE PROCESS STEP WAS NOT SPECIFIED. 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 20004419 ↗
• MalfunctionJul 13, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THREE (3) CLEARLINK LUER ACTIVATED VALVES BECAME LOOSE FROM NON-BAXTER SYRINGES. THIS WAS IDENTIFIED WHEN TRYING TO CONNECT THE PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319961 ↗
• MalfunctionNov 14, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY, ¿ABOUT TWENTY¿, CLEARLINK LUER ACTIVATED VALVES HAD IV (INTRAVENOUS) TUBING ¿UNWINDING ITSELF FROM THE HUB OR TUBING¿ WHEN IN USE WITH A CLEARLINK CONTINU-FLO SOLUTION SET, WHICH RESULTED IN LEAKS ONTO GOWNS AND BEDDING. THIS OCCURRED AT THE POINT OF ATTACHING THE IV TUBING TO THE HUB FOR A PATIENT INFUSION; WHEN THE IV SOLUTION WAS TURNED ON THE TUBING WOULD UNWIND ITSELF. 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 15791290 ↗
• MalfunctionSep 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVES LEAKED. IT WAS FURTHER REPORTED DURING CT/MRI THE IVS ARE HAVING "BLOW OUTS". THE EVENTS OCCURRED DURING "HIGH PRESSURE CONTRAST STUDIES". IT WAS FURTHER REPORTED THE CLEARLINK LUER ACTIVATED VALVES ARE NOT RECOMMENDED WITH HIGH CONTRAST INJECTIONS. 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 12548478 ↗
• MalfunctionFeb 26, 2021Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACKED UP INTO THE LINE WHILE USING CLEARLINK LUER ACTIVATED VALVE. THIS WAS IDENTIFIED DURING PATIENT USE. 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 11388412 ↗
• MalfunctionFeb 26, 2021Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACKED UP WHILE USING AN UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVES. THIS WAS IDENTIFIED DURING USE. 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 11385703 ↗
• MalfunctionNov 13, 2019No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE ¿HAD DIFFICULTY FLUSHING¿ WHEN USED IN CONJUNCTION WITH A 20 GAUGE NON-BAXTER IV CATHETER. THE ISSUE OCCURRED APPROXIMATELY ¿10-20 TIMES¿. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317957 ↗
• MalfunctionSep 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LUER LOCK OF CLEARLINK LUER ACTIVATED VALVE WAS MALFORMED. THE EVENT WAS FURTHER DESCRIBED AS THE CAP WOULD NOT SCREW ONTO THE END OF THE INTRAVENOUS CANNULA AS IT APPEARED THE CAP WAS DENTED. THIS WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980144 ↗
• MalfunctionMar 23, 2018Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE WOULD NOT PRIME WITH NORMAL SALINE SOLUTION. THIS EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367412 ↗
• MalfunctionMar 23, 2018Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE WOULD NOT PRIME WITH NORMAL SALINE SOLUTION. THIS EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367409 ↗

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-0190-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
• 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-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-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-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-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