CLEARLINK 2C8401Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00085412048932), received between Jan 24, 2018 and Sep 16, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Obstruction of Flow; No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796424 ↗
• MalfunctionApr 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE WAS LEAKING ¿AT THE AREA OF THE PORT¿. THIS WAS IDENTIFIED DURING A PATIENT INFUSION. THE DEVICE HAD BEEN ATTACHED TO AN IV (INTRAVENOUS) PIGGYBACK SET, THE LINES WERE PRIMED WHILE CONTAINED IN THE CHEMO HOOD, THEY WERE THEN TRANSPORTED TO THE UNIT (IVPB) IN A CHEMO TRANSPORT BAG AND HOOKED UP TO AN INFUSION PUMP FOR THE PATIENT INFUSION. SUBSEQUENTLY, THE LEAK WAS IDENTIFIED TOWARD THE END OF THE INFUSION WHEN THE TREATMENT WAS ALMOST FINISHED. 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 8562563 ↗
• MalfunctionApr 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM SOLUTION SET LEAKED. THE PRIMARY SOLUTION AND THE SECONDARY CHEMOTHERAPY MEDICATION WHERE ATTACHED AND PRIMED WHEN SENT TO THE UNIT. THE SET WAS CONNECTED TO AN UNSPECIFIED PUMP. WHEN THE NURSE INITIATED THE INFUSION, THE LEAK WAS OBSERVED AROUND THE PORT ON THE TUBING. 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 8515918 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED AT THE JUNCTION OF THE TUBING AND THE LUER VALVE. THIS WAS IDENTIFIED APPROXIMATELY FIVE MINUTES INTO A PATIENT INFUSION. THE PATIENT WAS RECEIVING AN INFUSION OF CISPLATIN WITH AN INFUSION PUMP (UNKNOWN PUMP RATE). 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 7902311 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED AT THE JUNCTION OF THE TUBING AND THE LUER VALVE. THIS WAS IDENTIFIED DURING SET UP, PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7902309 ↗
• MalfunctionMar 15, 2018Cut In Material; Cut In Material

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SOLUTION SET WAS CUT IN TWO PIECES. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7341617 ↗
• MalfunctionFeb 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK TUBE LEAKED AT THE CONNECTION TO THE DRIP CHAMBER. THE EVENT OCCURRED WHEN THE TECHNICIAN WAS PRIMING THE LINE WITH SALINE SOLUTION BEFORE ADDING ANY DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7299008 ↗
• MalfunctionFeb 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK TUBES LEAKED AT THE CONNECTION TO THE DRIP CHAMBER. THE EVENT OCCURRED WHEN THE TECHNICIAN WAS PRIMING THE LINE WITH SALINE SOLUTION BEFORE ADDING ANY DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7298992 ↗
• MalfunctionFeb 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THIS EVENT OCCURRED DURING SETUP AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Patient Involvement

  MAUDE report 7267021 ↗
• MalfunctionFeb 8, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THAT A HOLE WAS IDENTIFIED IN THE TUBING OF A CLEARLINK DEVICE. THIS EVENT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252606 ↗
• MalfunctionFeb 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED FROM ¿THE LOWER SIDE¿ OF THE SET DURING SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7240843 ↗
• MalfunctionJan 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM A CLEARLINK LUER ACTIVATED VALVE. THE LEAK WAS DISCOVERED FROM THE LOWER SIDE OF THE CHAMBER DURING USE. 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 7225137 ↗
• MalfunctionJan 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET WAS LEAKING AT THE CHAMBER. THIS EVENT WAS DISCOVERED DURING USE. 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 7216372 ↗

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-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-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-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-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