INTERLINK 2C7451Recalls & reported problems
Baxter International Inc. · Secondary Medication Set, Hanger, Lever Lock cannula, Male Luer Lock Adapter · Class 2
All models of INTERLINK (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412002576), received between Mar 20, 2018 and Oct 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
- Fluid/Blood Leak1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SYSTEM SECONDARY MEDICATION SET LEAKED TOTAL PARENTERAL NUTRITION (TPN) DURING PRIMING AT BEDSIDE. THE LOCATION OF THE LEAK WAS DESCRIBED AS "Y PORT". 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 23285839 ↗MalfunctionMar 10, 2023No Flow; No Flow
IT WAS REPORTED THAT AN INTERLINK SYSTEM SECONDARY MEDICATION SET WOULD NOT INFUSE. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH ZOSYN; APPROXIMATELY 6 HOURS AFTER BEING HUNG. THE PRIMARY INFUSION WAS SALINE AT 5CC. ALL CLAMPS WERE OPEN ON PRIMARY AND SECONDARY SETS. 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 16524063 ↗MalfunctionMar 20, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED THAT AN INTERLINK SECONDARY MEDICATION SET WOULD NOT CONNECT TO THE ACCESS PORT OF A SOLUTION SET. DURING SETUP, THE CUSTOMER WAS UNABLE TO PUNCTURE THE PORT OF THE PRIMARY SOLUTION SET WITH THE SECONDARY SET. 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 7355642 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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