CLEARLINK 2C8606Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412049014), received between May 9, 2018 and Sep 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918913 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM THE FIRST PORT (CLEARLINK). THE ISSUE WAS FURTHER DESCRIBED AS; UPON FLUSHING THE TUBING, A LEAK WAS OBSERVED FROM THE FIRST PORT RESULTING IN FLUID SQUIRTING OUT. HOWEVER, IT WAS UNSPECIFIED IF PATIENT WAS INVOLVED. 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 22730313 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING DISLODGED FROM THE SECOND PORT (CLEARLINK) OF A CLEARLINK SYSTEM EXTENSION SET RESULTING IN A BLOOD LEAK. 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 21200777 ↗
• MalfunctionApr 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED AT THE PORT. THE ISSUE WAS IDENTIFIED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210202 ↗
• MalfunctionDec 21, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT PRECIPITATE WAS OBSERVED WITHIN THE EXTENSION TUBING OF A CLEARLINK SYSTEM EXTENSION SET. IT WAS FURTHER REPORTED "WHEN THE ANESTHESIOLOGIST STARTED INFUSING THE PATIENT MEDICATION INTO THE TUBING THE SOLUTION AND THE MEDICATION CREATED A PRECIPITATE WITHIN THE PORTION OF THE EXTENSION TUBING¿. IT WAS ALSO REPORTED THE IV SOLUTION AND THE MEDICATION DO NOT HAVE ANY CONTRAINDICATIONS. 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 8189975 ↗
• MalfunctionMay 9, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET DISCONNECTED. THE ¿TUBING COMING APART AT THE HUB¿ WHEN THE TUBING WAS BEING ATTACHED TO THE IV CATHETER. THIS OCCURRED AFTER IV INSERTION. 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 7498424 ↗
• MalfunctionMay 9, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET DISCONNECTED. THE ¿TUBING COMING APART AT THE HUB¿ WHEN THE TUBING WAS BEING ATTACHED TO THE IV CATHETER. THIS OCCURRED AFTER IV INSERTION. 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 7498422 ↗

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-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-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-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-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-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