INTERLINK/BURETROL 2C7564Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00085412002781), received between Jun 4, 2018 and Sep 30, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953903 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TOP PIECE SPIKE AND TUBING DETACHED FROM THE BURETTE CYLINDER (CHAMBER) OF TWO (2) BURETROL SOLUTION SETS. THE EVENTS OCCURRED DURING USE IN THE ANESTHESIA DEPARTMENT. 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 25018334 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPIKE AND PROXIMAL FLUID TUBE OF A BURETROL SOLUTION SET DETACHED FROM THE BURETTE CHAMBER. THE ISSUE OCCURRED IN THE OPERATING ROOM DURING ANESTHESIA 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 25003897 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE "TOP PIECE (SPIKE AND PROXIMAL FLUID TUBE)" OF AN INTERLINK SYSTEM BURETROL SOLUTION SET DETACHED FROM THE CHAMBER CYLINDER OF THE SET. THE EVENT OCCURRED IN THE OPERATING ROOM DURING ANESTHESIA 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 25003895 ↗
• MalfunctionApr 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURETROL COMPONENT OF TWO (2) BURETROL SOLUTION SETS SEPARATED FROM THE TUBING. THIS OCCURRED DURING AN UNSPECIFIED OPERATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890605 ↗
• MalfunctionApr 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURETROL COMPONENT OF EIGHT (8) BURETROL SOLUTION SETS SEPARATED FROM THE TUBING. THIS OCCURRED DURING AN UNSPECIFIED OPERATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890600 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IV CHAMBER OF AN INTERLINK SYSTEM BURETROL SOLUTION SET PARTIALLY DETACHED FROM THE TUBING SET. THIS WAS OBSERVED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016559 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY INTERLINK BURETROL SOLUTION SETS EXPERIENCED A SEPARATION ISSUE OF BONDED COMPONENTS WHICH RESULTED IN A FLUID LEAK. THE SEPARATION ISSUE WAS DESCRIBED AS, ¿DETACHMENT AT THE CONNECTION POINT WHERE THE IV SPIKE LINE ATTACHES¿. THESE ISSUES OCCURRED DURING 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 23805779 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT LEAST TWO (2) INTERLINK BURETROL SOLUTION SETS EXPERIENCED A SEPARATION ISSUE OF BONDED COMPONENTS WHICH RESULTED IN A FLUID LEAK. THE SEPARATION ISSUE WAS DESCRIBED AS, ¿DETACHMENT AT THE CONNECTION POINT WHERE THE IV SPIKE LINE ATTACHES¿. THESE ISSUES OCCURRED DURING 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 23805582 ↗
• MalfunctionOct 21, 2025Backflow; Backflow

  IT WAS REPORTED THAT A BURETROL SOLUTION SET HAD SOLUTION BACKING UP INSTEAD OF FLOWING DOWNWARDS. THIS WAS OBSERVED BEFORE PATIENT CONNECTION. A NEW TUBING SET WAS USED TO CONTINUE THE SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351088 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF AN INTERLINK BURETROL SOLUTION SET SEPARATED FROM THE INSERTION SITE OF THE BURETTE CHAMBER WHICH RESULTED IN A FLUID LEAK. THIS ISSUE WAS DESCRIBED AS, ¿LEAK OCCURRED WHEN THE TUBING CAME COMPLETELY DISCONNECTED FROM THE INSERTION SITE OF THE BURETROL, WHICH APPEARED TO BE A COMPONENT THAT SHOULD HAVE BEEN SOLVENT BONDED¿. THIS ISSUE OCCURRED AFTER SPIKING A DEXTROSE INJECTION 10% BAG. 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 23318507 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE OF AN INTERLINK BURETROL SOLUTION SET SEPARATED FROM INSIDE THE DRIP CHAMBER WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED AFTER SPIKING A DEXTROSE INJECTION 10% BAG. 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 23318413 ↗
• MalfunctionMar 26, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF INTERLINK SYSTEM BURETROL SOLUTION SETS HAD CONNECTION ISSUES WITH CLEARLINK SYSTEM EXTENSION SETS. THE ISSUE WAS FURTHER DESCRIBED AS, THE RETRACTABLE COLLAR WAS NOT ENGAGED UPON CONNECTION. THE RETRACTABLE COLLAR DID NOT STAY ENGAGED UPON CONNECTION; THE RING THAT LOCKS IN PLACE WOULD "UNSCREW". THIS WAS DISCOVERED DURING USE; HOWEVER, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21702349 ↗
• MalfunctionJan 14, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT 'THE PORT WAS ABNORMAL AND REPLACED BY CAP' IN TWO (02) INTERLINK SYSTEM BURETROL SOLUTION SETS. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148955 ↗
• MalfunctionSep 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE DRIP CHAMBER OF TWO (2) INTERLINK SYSTEM BURETROL SOLUTION SETS COULD NOT BE FILLED WITH FLUID. THE BURETTE CHAMBER WAS FILLED WITH SOLUTION, BUT THE NEEDLE WOULD NOT ALLOW ANY FLUID TO BE RELEASED FROM THE BURETTE CHAMBER INTO THE DRIP CHAMBER. THIS OCCURRED DURING SET UP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158209 ↗
• MalfunctionSep 29, 2020Improper Flow or Infusion; Protective Measures Problem; Improper Flow or Infusion; Protective Measures Problem

  IT WAS REPORTED THAT UNKNOWN QUANTITY OF INTERLINK SYSTEM BURETROL SOLUTION SETS HAD AIR TRAPPED IN THE LINE WHILE BEING USED WITH A SPECTRUM PUMP RESULTING IN AIR ALARMS. THIS ISSUE WAS IDENTIFIED DURING USE OF THE DEVICES. 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 10600501 ↗
• MalfunctionSep 29, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT AIR, UPSTREAM, AND DOWNSTREAM OCCLUSION ALARMS WERE TRIGGERED ON A SPECTRUM PUMP WHILE BEING USED WITH UNKNOWN QUANTITY OF INTERLINK SYSTEM BURETROL SOLUTION SETS. IT WAS FURTHER REPORTED NO AIR OR OCCLUSIONS WERE NOTED IN THE LINES. THE WAS OBSERVED DURING USE OF THE SETS. 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 10600439 ↗
• MalfunctionJun 8, 2018No Flow; No Flow

  IT WAS REPORTED THAT AN INTERLINK BURETROL SOLUTION SET DID NOT FLOW DURING INFUSION. THE REPORTER STATED THAT AFTER 2-3 DOSES OF CEFEPIME WERE INFUSED USING THE SET, THE ¿DRIP BECAME SLUGGISH AND DID NOT DRIP ANYMORE¿. 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 7582579 ↗
• MalfunctionJun 4, 2018No Flow; No Flow

  IT WAS REPORTED THAT AN INTERLINK BURETROL SOLUTION SET WAS BLOCKED. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7566620 ↗

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-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
• 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