INTERLINK/BURETROLRecalls & reported problems across all models
Baxter Healthcare Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of INTERLINK/BURETROL by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2018 and Sep 30, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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
Reports received per month, all models
Most reported INTERLINK/BURETROL problems
Device problems
- Detachment of Device or Device Component10
- Fluid/Blood Leak9
- No Flow3
- Protective Measures Problem2
- Backflow1
- Component Misassembled1
- Fracture1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient3
- No Patient Involvement2
INTERLINK/BURETROL models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTERLINK/BURETROL 2C7564Set, administration, intravascular19 reports
- INTERLINK/BURETROL 2H7565Set, administration, intravascular1 report
Recent INTERLINK/BURETROL adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Baxter Healthcare Corporation products
- EXACTAMIX28 models · 6,739 reports · 13 recalls
- MiniCap3 models · 3,423 reports · 7 recalls
- Novum IQ3 models · 1,540 reports · 7 recalls
- CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
- CLEARLINK19 models · 710 reports · 4 recalls
- CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
- CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
- REPEATER6 models · 189 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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