INTERLINK 2C6401Recalls & reported problems
Baxter Healthcare Corporation · Solution Set, Injection Site, Lever Lock Cannula, Male Luer Lock Adapter with Retractable Collar · Class 2
All models of INTERLINK (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412002118), received between Jun 8, 2018 and Feb 15, 2023 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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, 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
Device problems
- Fluid/Blood Leak8
- Crack2
- Material Deformation1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A SALINE LEAK IN THE LINE OF AN INTERLINK SYSTEM SOLUTION SET. THE ISSUE WAS IDENTIFIED 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 16380426 ↗MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A INTERLINK SYSTEM SOLUTION SET HAD A SLOW DRIP FROM THE MIDDLE OF THE TUBING WHEN UNDER PRESSURE FROM THE UNSPECIFIED INFUSION PUMP. ADDITIONALLY, THE LEAK WAS NOTED TO BE "WEEPING THROUGH THE LINE WHEN UNDER PRESSURE FROM THE PUMP". THE EVENT OCCURRED 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 16216400 ↗MalfunctionJan 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING OF AN INTERLINK SYSTEM SOLUTION SET LEAKED DUE TO A CRACK. FURTHERMORE, THE LEAK WAS NOTED "MID TUBE". THE EVENT OCCURRED DURING AN UNSPECIFIED PATIENT INFUSION WHILE CONNECTED TO AN UNSPECIFIED PUMP. 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 16205929 ↗MalfunctionJan 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE MIDDLE OF THE TUBING. THE LEAK WAS FURTHER DESCRIBED AS A SLOW DRIP FROM THE MIDDLE OF THE TUBING WHEN UNDER PRESSURE FROM AN UNSPECIFIED INFUSION PUMP. THIS WAS OBSERVED DURING 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 16205828 ↗MalfunctionJan 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A INTERLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE MIDDLE OF THE TUBING. THE LEAK WAS FURTHER DESCRIBED AS A SLOW DRIP FROM THE MIDDLE OF THE TUBING WHEN UNDER PRESSURE FROM THE UNSPECIFIED INFUSION PUMP. THIS WAS OBSERVED DURING 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 16195230 ↗MalfunctionJan 18, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A CRACK IN THE TUBING OF TWO (2) INTERLINK SYSTEM SOLUTION SETS WHICH RESULTED IN A LEAK. THIS WAS IDENTIFIED AFTER HANGING AN UNSPECIFIED DRUG AND CONNECTING THE TUBING TO AN UNSPECIFIED PUMP. 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 16195055 ↗MalfunctionJan 17, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SYSTEM SOLUTION SET HAD A CRACK IN THE MID TUBING WHICH RESULTED IN A LEAK. THE CRACK AND LEAK WERE DISCOVERED IN THE TUBING AFTER HANGING THE DRUG AND CONNECTING TUBING TO THE PUMP. 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 16186959 ↗MalfunctionJun 18, 2020Material Deformation; No Flow; Material Deformation; No Flow
IT WAS REPORTED THAT THREE (3) INTERLINK SYSTEM SOLUTION SETS WOULD NOT FLOW DURING USE WITH SODIUM CHLORIDE. IT WAS FURTHER REPORTED THAT THE END OF THE TUBING WAS KINKED. 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 10167691 ↗MalfunctionJun 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SOLUTION SET WAS LEAKING FROM THE PORT. THIS OCCURRED DURING 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 7584086 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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