CLEARLINK/BURETROL 2H8864Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412071749), received between Mar 15, 2018 and Aug 15, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 17, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP BURETROL SOLUTION SETS WERE NOT FLOWING. THIS WAS OBSERVED DURING UNSPECIFIED PROCESS STEPS. 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 15242511 ↗
• MalfunctionOct 26, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP BURETROL SOLUTION SET WAS CRACKED AND AS A RESULT LEAKED. THIS WAS DESCRIBED AS THE DEVICE ¿WAS PRIMED WITH A SALINE TO ADMINISTER CHEMO AND BURETROL LEAKED¿. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10737755 ↗
• MalfunctionApr 19, 2019Device Displays Incorrect Message; Improper Flow or Infusion; Device Displays Incorrect Message; Improper Flow or Infusion

  IT WAS REPORTED THAT TWO (2) CLEARLINK BURETROL SOLUTION SETS HAD BUBBLES ACCUMULATED BENEATH THE DRIP CHAMBER AND TUBE WHEN USING THE SETS. THE BAXTER INFUSION PUMP DISPLAYED AN AIR ALARM WHILE RUNNING 10% DEXTROSE. THIS WAS NOTED DURING PRODUCT 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 8533591 ↗
• MalfunctionMay 21, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE DRIP CHAMBER AND BURETROL OF A CLEARLINK SYSTEM BURETROL SOLUTION SET DISCONNECTED. THE NURSE NOTICED THAT THE DRIP CHAMBER WAS SLIGHTLY CROOKED. UPON FURTHER INSPECTION, THE DRIP CHAMBER AND BURETROL WERE NOT CONNECTED AND WERE PULLED APART WITH LITTLE EFFORT. THIS EVENT OCCURRED DURING PATIENT INFUSION. 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 7530396 ↗
• MalfunctionMay 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WAS AIR IN THE LINE OF A CLEARLINK BURETROL SOLUTION SET. THIS OCCURRED DURING INFUSION. 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 7520551 ↗
• MalfunctionMay 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WAS AIR IN THE LINE OF TWO (2) CLEARLINK BURETROL SOLUTION SETS. THIS OCCURRED DURING INFUSION. 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 7520518 ↗
• MalfunctionApr 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AIR ENTERED THE TUBING OF TWO (2) CLEARLINK SYSTEM BURETROL SOLUTION SETS. AT THE TIME OF THE REPORTED PROBLEM, A LACTATED RINGER SOLUTION BAG WAS BEING DRAWN THROUGH THE SET; HOWEVER, THE PROCESS STEP AND PATIENT INVOLVEMENT WAS NOT SPECIFIED. 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 7464592 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AIR WAS IDENTIFIED IN THE TUBING OF CLEARLINK SYSTEM BURETROL SOLUTION SET. THE AIR IN THE TUBING WAS DISCOVERED WHEN THE BUERTROL CHAMBER WAS EMPTY. 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 7404304 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WAS AIR IN THE TUBING OF A CLEARLINK BURETROL SOLUTION SET DURING INFUSION. THE REPORTER STATED THAT THE SET HAD ¿EMPTIED OUT AND SHOT AIR THROUGH THE TUBING.¿ 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 7341539 ↗

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-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-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-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