CLEARLINK 2N8341Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412071657), received between Oct 12, 2018 and Jun 28, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SETS LEAKED FROM ONE OF THE PORTS (LUER CONNECTOR) WHEN CONNECTED; A DISCONNECTION WAS NOTED. THIS OCCURRED DURING PATIENT USE. NON-BAXTER SETS WERE USED TO RESOLVE 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 19639307 ↗
• MalfunctionSep 27, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SET WOULD NOT FLUSH WITH ALL CLAMPS OPEN. THE ISSUE WAS IDENTIFIED DURING PATIENT 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 15491657 ↗
• MalfunctionSep 27, 2022Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SET WOULD NOT FLUSH WITH ALL CLAMPS OPEN AND LEAKED AT THE UPPER HUB. THE ISSUE WAS IDENTIFIED DURING PATIENT 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 15490749 ↗
• MalfunctionSep 26, 2022Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SET WOULD NOT FLUSH WHILE ALL CLAMPS WERE OPENED AND LEAKED AT THE UPPER HUB. 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 15485552 ↗
• MalfunctionSep 22, 2022No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH FOUR (4) CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SETS. THIS ISSUE WAS FURTHER DESCRIBED AS THE SET WOULD NOT FLUSH WHILE CLAMPS WERE OPENED. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463120 ↗
• MalfunctionSep 22, 2022Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SET LEAKED COMING FROM THE BONDED SECTION OF THE END LUER AND THE TUBING. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463115 ↗
• MalfunctionJul 31, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP THREE LEAD EXTENSION SETS WERE CLOGGED AND WOULD NOT FLUSH. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. 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 10351078 ↗
• MalfunctionNov 9, 2018No Flow; No Flow

  IT WAS REPORTED THAT THE LUMENS OF THREE (3) CLEARLINK NON-DEHP THREE LEAD EXTENSION SETS WOULD NOT FLUSH. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. 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 8057463 ↗
• MalfunctionNov 9, 2018No Flow; No Flow

  IT WAS REPORTED THAT THE LUMENS OF FOUR (4) CLEARLINK NON-DEHP THREE LEAD EXTENSION SETS WOULD NOT FLUSH. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. 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 8057420 ↗
• MalfunctionOct 12, 2018No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH THREE (3) CLEARLINK SYSTEM EXTENSION SETS. THE SETS WERE UNABLE TO BE FLUSHED. THIS EVENT OCCURRED DURING AN UNSPECIFIED PROCESS STEP AND IT WAS UNKNOWN IF A 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 Consequences Or Impact To Patient

  MAUDE report 7963007 ↗

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