INTERLINK 2N3326Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412004648), received between Sep 17, 2018 and Sep 28, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921516 ↗
• MalfunctionAug 31, 2023No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOWING THROUGH AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS. THIS WAS DISCOVERED 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 17662885 ↗
• MalfunctionMay 1, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT TWO (2) INTERLINK T-CONNECTOR EXTENSION SETS WOULD NOT PRIME. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10019054 ↗
• InjuryDec 12, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED DURING USE WITH AN INTERLINK T-CONNECTOR EXTENSION SET, A DISCONNECTION OCCURRED ¿FROM THE HUB OF THE IV CATHETER¿ WHICH RESULTED IN BLOOD LEAK. THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. IT WAS REPORTED AN APPROXIMATE BLOOD LOSS OF ¿FIVE TO SIX ML¿ OCCURRED. IT WAS REPORTED A TRANSFUSION WAS NEEDED (NO FURTHER DETAILS PROVIDED). AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9457173 ↗
• MalfunctionOct 16, 2018Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED AND THE TUBING OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET WAS CUT AND STICKING OUT OF THE PACKAGING THROUGH THE SIDE SEAL. THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7969344 ↗
• InjurySep 17, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT A PATIENT BEING TREATED WITH AN INTERLINK T-CONNECTOR EXTENSION SET EXPERIENCED A DISCONNECTION OF THE SET RESULTING IN A "BLOOD SPILL ON THE BEDSIDE". THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7881160 ↗
• MalfunctionSep 17, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT A PATIENT BEING TREATED WITH AN INTERLINK T-CONNECTOR EXTENSION SET EXPERIENCED A DISCONNECTION OF THE SET RESULTING IN A "BLOOD SPILL ON THE BEDSIDE". THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7881158 ↗
• InjurySep 17, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT A PATIENT BEING TREATED WITH AN INTERLINK T-CONNECTOR EXTENSION SET EXPERIENCED A DISCONNECTION OF THE SET RESULTING IN A "BLOOD SPILL ON THE BEDSIDE". THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7881151 ↗
• MalfunctionSep 17, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  A PEDIATRIC PATIENT EXPERIENCED BLOOD LOSS INVOLVING AN INTERLINK T-CONNECTOR EXTENSION SET. IT WAS REPORTED THE EXTENSION SET DISCONNECTED DURING USE CAUSING A ¿BLOOD SPILL ON THE BEDSIDE¿. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. THE NURSE REPORTED THE SET WAS ¿NOT MAINTAINING THE CONNECTION, DISCONNECTING AND THEN BLOOD OR FLUIDS BACKING UP¿. THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7881150 ↗