CLEARLINK/BURETROL 2C8864Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00085412071121), received between May 15, 2018 and Sep 25, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K123874); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Backflow

  It was reported that a Clearlink Buretrol Solution Set experienced medication backing up into the tubing and Buretrol 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 50900099 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF BURETROL SOLUTION SETS LEAKED AT THE ROLLER CLAMP SECTION. 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 25290458 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Air/Gas in Device; Detachment of Device or Device Component; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD THE FILTER VALVE SEPARATE FROM THE DRIP CHAMBER; AIR LEAKED INTO THE CHAMBER. THIS WAS OBSERVED DURING PRIMING. 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 19460694 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Air/Gas in Device; Detachment of Device or Device Component; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD THE FILTER VALVE SEPARATE FROM THE DRIP CHAMBER; AIR LEAKED INTO THE CHAMBER. THIS WAS OBSERVED 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 19460575 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF THREE (3) CLEARLINK SYSTEM BURETROL SOLUTION SETS COMPLETELY SEPARATED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19452721 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE BENEATH THE CHAMBER OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS WHICH RESULTED IN A LEAK. THE ISSUE WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222533 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY FOUR (4) TO FIVE (5) CLEARLINK SYSTEM BURETROL SOLUTION SETS WERE LEAKING FROM AN UNSPECIFIED LOCATION. THIS WAS DISCOVERED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164856 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE BENEATH THE CHAMBER OF AN UNSPECIFIED QUANTITY [AT LEAST FIVE (5)] OF CLEARLINK SYSTEM BURETROL SOLUTION SETS WHICH RESULTED IN A LEAK. THE ISSUE WAS IDENTIFIED DURING USE. 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 18048289 ↗
• MalfunctionOct 12, 2023Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM BURETROL SOLUTION SET HAD A HOLE RIGHT BELOW THE CHAMBER OF THE TUBING WHICH RESULTED IN LARGE AMOUNTS OF AIR IN THE INTRAVENOUS LINE. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 17925866 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CAP OF A CLEARLINK SYSTEM BURETROL SOLUTION SET WAS DETACHED FROM THE STERILE TUBE. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776933 ↗
• MalfunctionJul 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED IN THE DRIP CHAMBER OF TWO (2) CLEARLINK SYSTEM BURETROL SOLUTION SETS. THE PM WAS FURTHER DESCRIBED AS WHITE PARTICULATE IN ONE CHAMBER AND THE OTHER HAD BLUE PARTICULATE. THIS ISSUE WAS IDENTIFIED WHILE PRIMING LACTATED RINGERS PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093614 ↗
• MalfunctionSep 6, 2019Reflux within Device; Improper Flow or Infusion; Reflux within Device; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD AIR IN LINES AND FLUID BACKING UP INTO THE DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8971212 ↗
• MalfunctionSep 6, 2019Reflux within Device; Improper Flow or Infusion; Reflux within Device; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD AIR IN LINES AND FLUID BACKING UP INTO THE DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. 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 8971210 ↗
• MalfunctionSep 6, 2019Reflux within Device; Improper Flow or Infusion; Reflux within Device; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD AIR IN LINES AND FLUID BACKING UP INTO THE DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. 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 8971207 ↗
• MalfunctionMar 20, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BUBBLE FORMATIONS WERE OBSERVED IN THE LINES OF SIX (6) CLEARLINK BURETROL SOLUTION SETS. THE REPORTER STATED THAT "IT APPEARS TO OCCUR AT THE SHUT OFF VALVE.". THIS WAS IDENTIFIED PRIOR TO USE ON A PATIENT EITHER WHILE PRIMING OR AFTER BEING PRIMED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8437208 ↗
• MalfunctionAug 14, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LINE OF CLEARLINK BURETROL SOLUTION SETS WAS CUT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7781095 ↗
• MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK BURETROL SOLUTION SET WAS LEAKING AT THE DRIP CHAMBER. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7687635 ↗
• MalfunctionMay 15, 2018Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM BURETROL SOLUTION SETS WERE UNABLE TO BE PRIMED. THESE EVENTS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7516155 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123874. One submission often covers many models, so check the product and lot details in each record.

• Z-2613-2014 · Jul 14, 2014 · Terminated
  ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is S
• Z-2614-2014 · Jul 14, 2014 · Terminated
  ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid pat
• Z-2615-2014 · Jul 14, 2014 · Terminated
  ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***F