CLEARLINK/BURETROL 2H8865Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412071183), received between Jul 20, 2022 and Mar 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LUER VALVES OF THREE (3) CLEARLINK SYSTEM NON-DEHP BURETROL SETS WERE "LOOSE AND NOT BONDED" AND SUBSEQUENTLY THE LUER SEPARATED FROM THE TUBING. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064672 ↗

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