CLEARLINK/BURETROL 2C8862Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412073354), received between Dec 20, 2018 and Oct 24, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Crack; Crack

  IT WAS REPORTED THAT A CLEARLINK SYSTEM BURETROL SOLUTION SET CHAMBER CRACKED. DURING AN UNSPECIFIED INFUSION ON A PEDIATRIC PATIENT, THE UNKNOWN INFUSION PUMP WAS BEEPING, AND A STAFF MEMBER HEARD A ¿LOUD POP¿ ORIGINATING ¿FROM THE CHAMBER OF THE TUBING¿. THE BURETROL CHAMBER WAS OBSERVED ¿CRACKED AND SHATTERED¿. 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 20530034 ↗
• MalfunctionOct 14, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS HAD AIR IN THE LINE; FURTHER DESCRIBED AS, "BUBBLES BACK FLOWING". THIS OCCURRED 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 20446735 ↗
• MalfunctionMar 31, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE DRIP CHAMBER CAME APART FROM THE BURETTE CHAMBER OF A CLEARLINK SYSTEM BURETROL SOLUTION SET. THIS WAS IDENTIFIED WHEN PRIMING WITH 0.9% NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595804 ↗
• MalfunctionMar 16, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM BURETROL SOLUTION SET DISCONNECTED BELOW THE DRIP CHAMBER. THIS WAS IDENTIFIED OUT OF THE PACKAGE, BEFORE SPIKING INTRAVENOUS (IV) FLUIDS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496855 ↗
• MalfunctionAug 9, 2019Fluid/Blood Leak; Free or Unrestricted Flow; Fluid/Blood Leak; Free or Unrestricted Flow

  IT WAS REPORTED THAT A CLEARLINK BURETROL SOLUTION SET ¿FILLED DESPITE THE VALVE BEING CLAMPED. IT THEN STARTED LEAKING OUT THE TOP OF THE BURETROL CHAMBER WHILE IT WAS HANGING ON AN IV (INTRAVENOUS) POLE. THE IV WAS NEVER HOOKED TO A PATIENT.¿ THIS WAS IDENTIFIED WHILE PRIMING THE BURETROL TUBING WITH NORMAL SALINE. 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 8880148 ↗
• MalfunctionJul 1, 2019Filling Problem; Filling Problem

  IT WAS REPORTED THAT A CLEARLINK BURETROL SOLUTION SET OVER-INFUSED. IT WAS FURTHER REPORTED THAT THE BURETROL TUBING WAS FILLED WITH SALINE TO THE TOP DESPITE THE VENT BEING CLAMPED. THIS WAS IDENTIFIED DURING AN UNSPECIFIED 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 8749095 ↗
• MalfunctionJul 1, 2019Filling Problem; Fluid/Blood Leak; Filling Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK BURETROL SOLUTION SET FILLED DESPITE THE VALVE BEING CLAMPED. IT WAS FURTHER REPORTED THAT LEAKING WAS OBSERVED OUT OF THE TOP OF THE BURETROL CHAMBER WHILE HANGING THE SET ON AN INTRAVENOUS (IV) POLE. THIS WAS IDENTIFIED DURING PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8749047 ↗
• MalfunctionDec 20, 2018Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT THE BURETROL COMPONENT OF A CLEARLINK BURETROL SOLUTION SET COLLAPSED DURING INFUSION. THE REPORTER STATED THAT THE BURETROL WAS ¿AUTOMATICALLY SUCKING IN¿ AND COLLAPSING. MULTIPLE ATTEMPTS WERE MADE BY THE CUSTOMER TO RECTIFY THE ISSUE, SUCH AS ENSURING THE CLAMPS WERE RELEASED; HOWEVER, THE BURETROL CONTINUED COLLAPSING. AFTER 16 HOURS OF INFUSION, THE BURETROL COMPONENT CRACKED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8184862 ↗

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