CLEARLINK 2N8371Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412048925), received between Jan 26, 2022 and Sep 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941448 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755839 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS CAME APART OR RUPTURED DURING PATIENT USE WITH COMPUTED TOMOGRAPHY (CT) CONTRAST. THE SETS CAME APART OR LEAKED EITHER AFTER TIGHTENING THE CAPS (CLEARLINK) OR AT THE Y-SITE (JUNCTION). 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 24692843 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS CAME APART OR RUPTURED DURING PATIENT USE WITH COMPUTED TOMOGRAPHY (CT) CONTRAST. THE SETS CAME APART OR LEAKED EITHER AFTER TIGHTENING THE CAPS (CLEARLINK) OR AT THE Y-SITE (JUNCTION). 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 24692664 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS CAME APART OR RUPTURED DURING PATIENT USE WITH COMPUTED TOMOGRAPHY (CT) CONTRAST. THE SETS CAME APART OR LEAKED EITHER AFTER TIGHTENING THE CAPS (CLEARLINK) OR AT THE Y-SITE (JUNCTION). 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 24692454 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS CAME APART OR RUPTURED DURING PATIENT USE WITH COMPUTED TOMOGRAPHY (CT) CONTRAST. THE SETS CAME APART OR LEAKED EITHER AFTER TIGHTENING THE CAPS (CLEARLINK) OR AT THE Y-SITE (JUNCTION). 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 24692284 ↗
• MalfunctionNov 1, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT WAS A BACK FLOW OF BLOOD IN A CLEARLINK SYSTEM Y-TYPE CATHETER EXTENSION SET WHICH LEAKED AT THE BIFURCATION. THERE WAS LESS THAN 0.5 CC OF PATIENT BLOOD LEAKING OUT OF THE DEVICE. THIS OCCURRED DURING SALINE FLUSH. THE TUBING WAS CHANGED AS A RESULT OF THE EVENT. 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 20592654 ↗
• MalfunctionOct 2, 2024Backflow; Backflow

  IT WAS REPORTED THAT BLOOD BACK FLOWED IN A CLEARLINK SYSTEM NON-DEHP Y-TYPE CATHETER EXTENSION SET. ONCE THE EXTENSION SET IS CONNECTED TO THE PATIENT CATHETER, ¿BLOOD COMES OUT BETWEEN THE TWO TUBES AT THE BIFURCATION WHEN FLUSHING SALINE¿. 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 20353512 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP Y-TYPE CATHETER EXTENSION SETS WERE LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAKS 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 19012455 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM, NON-DEHP Y-TYPE CATHETER EXTENSION SETS WERE LEAKING FROM THE WHITE WING JUST BELOW THE LUER ACTIVATED VALVE. THIS OCCURRED DURING FLUSHING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847280 ↗
• MalfunctionJan 26, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SEVEN (7) CLEARLINK SYSTEM NON-DEHP Y-TYPE CATHETER EXTENSION SETS HAD A HOLE IN THE PART THAT CONNECTS TO THE INTRAVENOUS (IV) LINE. THE WAS IDENTIFIED DURING PATIENT USE, WHEN THE NURSE WAS TRYING TO FLUSH THE LINE IN THE PATIENTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359528 ↗

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-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-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-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