CLEARLINK/BURETROLRecalls & reported problems across all models

We found 4 models of CLEARLINK/BURETROL by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2018 and Sep 25, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CLEARLINK/BURETROL problems

CLEARLINK/BURETROL models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CLEARLINK/BURETROL 2C8864

  Set, administration, intravascular
  18 reports
• CLEARLINK/BURETROL 2H8864

  Set, administration, intravascular
  10 reports
• CLEARLINK/BURETROL 2H8865

  Set, administration, intravascular
  4 reports
• CLEARLINK/BURETROL 2R8864

  Set, administration, intravascular
  2 reports

Recent CLEARLINK/BURETROL adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING OF A CLEARLINK BURETROL ADD-ON SET WHICH RESULTED IN A FLUID LEAK. WHILE PREPARING TO PRIME THE SET WITH BLOOD PRIOR TO PATIENT USE, IT APPEARED AS THOUGH THERE WAS A HOLE IN TUBING WHERE THE SLIDE CLAMP WAS WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536817 ↗
• MalfunctionDec 31, 2025Filling Problem; Air/Gas in Device; Filling Problem; Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE TWO (2) EVENTS INVOLVED WITH BURETROL ADD-ON SETS THAT HAD AIR IN THE TUBING BELOW THE BURETROL (WHICH HAD FLUID IN IT) AND BELOW THE PUMP ALTERNATING WITH FLUID. THE EVENT WAS FURTHER DESCRIBED AS "COULD HAVE BEEN AN OVER-INFUSION THAT WAS MINIMIZED BY HAVING A BURETROL, THEREBY LIMITING FLUID". 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 23936950 ↗
• MalfunctionDec 31, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM BURETROL SET HAD LARGE SPACES OF AIR IN THE TUBING. THE DEVICE CONTAINED DEXTROSE 5% SOLUTION. 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 23936096 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP BURETROL SOLUTION SET LEAKED AT THE AREA NEAR THE LOWEST INJECTION PORT AND DRIPPED ON THE FLOOR. THE ISSUE OCCURRED DURING PATIENT INFUSION WITH VINCRISTINE AND METHOTREXATE. THE METHOTREXATE LINE (CLAMPED AND NOT INFUSING) WAS CONNECTED TO THE VINCRISTINE PRIMARY LINE AT THE LOWEST PORT. WHEN THE VINCRISTINE HAD INFUSED 10ML, THE AREA NEAR THE LOWEST INJECTION PORT ON THE METHOTREXATE LINE LEAKED; THERE WAS A VISIBLE "KINK" AT THE LEAK LOCATION. 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 22816808 ↗
• MalfunctionAug 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH AN UNSPECIFIED QUANTITY (AT LEAST FIVE) CLEARLINK BURETROL SOLUTION SETS. IT WAS OBSERVED THAT THE IV (INTRAVENOUS) SOLUTION STOPS FLOWING WITHIN A FEW MINUTES AFTER FLUSHING. THE STOPPER WAS NOT COMPRESSING OR CAUSING THE FLOW TO STOP. THE IV SOLUTION STARTS TO BACK UP, REQUIRING A SECOND FLUSH TO CONTINUE FUNCTIONING. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THIS 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 19972890 ↗
• 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 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK BURETROL SOLUTION SETS LEAKED. THE SPIKE WOULD DISCONNECT FROM THE IV (INTRAVENOUS) BAG FROM A SMALL TUG OR MOVEMENT CAUSING MEDICATED SOLUTION (MAGNESIUM SOLUTION) TO ¿RUN OUT RAPIDLY TO THE FLOOR OR ON THE NURSES.¿ 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 19460521 ↗
• 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 ↗

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