CLEARLINK 2H8401Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412049090), received between Jan 25, 2018 and Nov 26, 2024 — 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.

• MalfunctionNov 26, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS LEAKED. THE TUBING HAS SEVERED/DETACHED AT THE PROXIMAL INSERTION SITE. THIS OCCURRED AT THE END OF CHEMOTHERAPY TREATMENT, AFTER RINSING. 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 20785107 ↗
• MalfunctionSep 26, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET BROKE BELOW THE LOWER Y-SITE WHILE PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486976 ↗
• MalfunctionJul 13, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LINE WAS "SPLITTING HORIZONTALLY" WHICH RESULTED IN A LEAK OF AN UNKNOWN CHEMOTHERAPY DRUG. IT WAS FURTHER REPORTED THAT ONCE THE LINE STARTED TO SPLIT, THE BLUE SLIDE WOULD PUSH THE TUBING AND CAUSE THE ALARM TO GO OFF AND WHEN THE PUMP WAS OPENED, SALINE OR CHEMOTHERAPY DRUG WOULD SPILL OUT. THIS ISSUE WAS FOUND WHILE ATTACHED TO THE PATIENT. THE DEVICE WAS USED WITH FLOGARD PUMP. THE CHEMOTHERAPY DRUG WAS REPORTED AS "INFLIXIMAB, NIVOLUMAB OR PEMBROLIZUMAB. 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 12158998 ↗
• MalfunctionJul 12, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS SPLITTING HORIZONTALLY WHICH RESULTED IN A LEAK OF CHEMOTHERAPY DRUG. THE SET WAS USED WITH A FLOGARD PUMP. IT WAS FURTHER REPORTED THAT ONCE THE TUBING STARTED TO SPLIT, THE BLUE SLIDE WOULD PUSH THE TUBING AND CAUSE THE ALARM TO GO OFF AND WHEN THE PUMP WAS OPENED, SALINE OR CHEMOTHERAPY DRUG WOULD SPILL OUT. THIS ISSUE WAS IDENTIFIED WHILE ATTACHING THE SET TO THE PATIENT. 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 12153801 ↗
• MalfunctionOct 26, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE MALE LUER LOCK OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET HAD A CONNECTION ISSUE TO THE CAP OF THE PATIENT¿S CATHETER IV. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE END OF THE CONNECTOR KEEPS TURNING WITHOUT SECURING THE CONNECTION TO THE CAP OF THE CATHETER IV.¿ THIS ISSUE WAS OBSERVED AT THE TIME OF PATIENT CONNECTION AFTER PRIMING WAS COMPLETED. 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 10734819 ↗
• MalfunctionApr 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS LEAKED FROM THE TUBING. THE LEAK WAS DISCOVERED 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 Consequences Or Impact To Patient

  MAUDE report 8520395 ↗
• MalfunctionJan 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK LUER ACTIVATED VALVE BECAME SLICED WHEN THE NURSE CLOSED THE SLIDE CLAMP. 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 8264651 ↗
• MalfunctionDec 28, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE "SLIDE OR ROLLER" CLAMP ON A CLEARLINK SOLUTION SET WAS CLOSED, IT SLICED THE TUBING AND CAUSED A LEAK. THIS WAS IDENTIFIED WHILE IN USE ON A PATIENT TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC DRUG WITH AN INFUSION PUMP. THE REPORTER STATED THAT 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 8202514 ↗
• MalfunctionFeb 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET WAS LEAKING. THIS EVENT OCCURRED DURING PATIENT INFUSION OF ZOLEDRONIC ACID WHILE USING AN UNSPECIFIED INFUSION PUMP. THE LOCATION OF THE LEAK WAS NOT SPECIFIED. 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 7276753 ↗
• MalfunctionFeb 6, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE BLUE SLIDE CLAMP PUNCTURED THE TUBING OF A CLEARLINK SOLUTION SET WHEN THE TUBING WAS BEING INSERTED INTO AN UNSPECIFIED BAXTER INFUSION PUMP. THIS OCCURRED DURING INFUSION, AND LED TO A LEAK OF AN UNSPECIFIED CHEMOTHERAPY DRUG. 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 7245516 ↗
• MalfunctionJan 25, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED. THIS OCCURRED DURING INFUSION USING AN UNSPECIFIED INFUSION PUMP. THE ISSUE WAS NOTICED WHEN THE PUMP PRESENTED AN OCCLUSION ALARM. WHEN THE DOOR OF THE PUMP WAS OPENED, THE SET WAS FOUND TO BE WET DUE TO THE BLUE SLIDE CLAMP PUNCTURING THE TUBING. THIS LED TO A LEAK OF APPROXIMATELY 10ML OF CHEMOTHERAPY SOLUTION ONTO THE PATIENT¿S SKIN. 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 7218413 ↗

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-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-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-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