INTERLINK 2N3328Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00085412004662), received between Aug 19, 2020 and Mar 3, 2026 — classified as 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).

8 other recalls cover devices cleared under the same FDA submission (K921899); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Backflow; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK NEAR THE DISTAL END OF AN INTERLINK NON-DEHP T-CONNECTOR EXTENSION SET WHICH RESULTED IN THE PATIENT¿S BLOOD BACKING UP INTO THE LINE AND LEAKING FROM THE CRACKED DISTAL END. DURING USE OF THE INTERLINK SET, IT WAS OBSERVED THAT BLOOD BACKED UP IN THE LINE, AND WHEN STAFF ATTEMPTED TO FLUSH THE SET, A MIXTURE OF BLOOD AND SALINE WAS OBSERVED LEAKING FROM A CRACK NEAR THE DISTAL END OF THE DEVICE. THE CRACK WAS LOCATED ON THE DISTAL END COMPONENT/HARD PLASTIC WHERE THE FLUSH CONNECTS. IT WAS ESTIMATED THAT THE NEONATE PATIENT LOST APPROXIMATELY 1¿2 ML OF BLOOD. THE PATIENT DID RECEIVE A BLOOD TRANSFUSION LATER THAT DAY; HOWEVER, THIS WAS ATTRIBUTED TO THE PATIENT¿S UNDERLYING CONDITION AND NOT NECESSARILY RELATED TO THE SMALL VOLUME OF BLOOD LOSS FROM THE DEVICE ISSUE, THOUGH IT MAY HAVE CONTRIBUTED MARGINALLY TO TIMING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24503299 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET LEAKED FROM THE T-CONNECTOR. THE DEVICE WAS CONNECTED TO A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER). THE DEVICE CONTAINED IVF (INTRAVENOUS FLUIDS). 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 24484013 ↗
• MalfunctionFeb 2, 2026

  T-CONNECTOR DIRECTLY CONNECTED TO THE PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] HAS A VISIBLE, SLOWLY LEAKED IVF [INTRAVENOUS FLUIDS].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229420 ↗
• MalfunctionDec 18, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT AN INTERLINK NON-DEHP T-CONNECTOR EXTENSION SET HAD A CONNECTION ISSUE. THE CONNECTION ISSUE WAS DESCRIBED AS THE SET FAILED TO CONNECT TO THE NEEDLE AS THERE WAS A DEFORMITY OBSERVED OF THE LUER LOCK. 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 23838813 ↗
• MalfunctionJul 25, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET CRACKED AT THE LUER CONNECTOR RESULTING IN A LEAK. THIS WAS OBSERVED DURING PATIENT USE. THE LOCATION WAS FURTHER DESCRIBED AS "CRACK AT HOUSING WHERE TUBING CONNECTS IV CONNECTION". 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 22609499 ↗
• MalfunctionJun 5, 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 NON-DEHP EXTENSION SET SEPARATED FROM THE Y-SITE. THIS ISSUE WAS DESCRIBED AS A BREAK IN THE LINE AS THE Y TUBING BOTTOM BECAME COMPLETELY DETACHED. THE SEPARATION OF THE BONDED COMPONENTS RESULTED IN A LEAK. 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 22152481 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM T-CONNECTOR EXTENSION SETS LEAKED AT THE BONDED SITE. THE PROCESS STEP 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 21169736 ↗
• MalfunctionOct 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SEPTUM OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET "DISLODGED FROM ITS HOME". THE EVENT OCCURRED DURING AN UNKNOWN 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 20493810 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SEPTUM OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET "DISLODGED FROM ITS HOME". THE EVENT OCCURRED DURING AN UNKNOWN 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 20286019 ↗
• MalfunctionSep 23, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET WAS LOOSE FROM THE MALE CONNECTOR. THIS WAS OBSERVED DURING 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 20284119 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SPLIT SEPTUM OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET DISLODGED FROM ITS HOME. THIS OCCURRED 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 20282439 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SPLIT SEPTUM OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET DISLODGED FROM ITS HOME. THIS OCCURRED 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 20280507 ↗
• MalfunctionSep 20, 2024Break; Break

  DURING EVALUATION OF A RETURNED INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET, IT WAS OBSERVED THAT THE T-CONN HOUSING WAS DAMAGED. 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 20274222 ↗
• MalfunctionSep 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SEPTUM OF TWO (2) NTERLINK SYSTEM T-CONNECTOR EXTENSION SETS "DISLODGED FROM ITS HOME". THE EVENT OCCURRED DURING AN UNKNOWN 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 20197292 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED THAT MALE PORTION OF THE LUER LOCK ADAPTER OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS WERE DAMAGED WHICH PREVENTED THE CONNECTION TO THE CATHETER HUB. THIS WAS NOTICED WHILE ATTEMPTING TO CONNECT THE T-CONNECTOR TO CATHETER HUB DURING VASCULAR ACCESS. 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 20136005 ↗
• MalfunctionSep 3, 2024Fitting Problem; Material Deformation; Fitting Problem; Material Deformation

  IT WAS REPORTED THAT THE LUER LOCK ADAPTER (MALE PORTION) OF AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET WAS MISSHAPEN (DAMAGED) WHICH PREVENTED THE CONNECTION TO THE CATHETER HUB. THIS WAS NOTICED WHILE CONNECTING THE SET DURING INTRAVENOUS PLACEMENT. 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 20130625 ↗
• MalfunctionSep 3, 2024Fitting Problem; Material Deformation; Fitting Problem; Material Deformation

  IT WAS REPORTED THAT LUER LOCK ADAPTER (MALE PORTION) OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS WERE MISSHAPEN (DAMAGED) WHICH PREVENTED THE CONNECTION TO THE CATHETER HUBS. THIS WAS NOTICED WHILE CONNECTING THE SETS DURING INTRAVENOUS PLACEMENT. 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 20130116 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT MALE PORTION OF THE LUER LOCK ADAPTER OF TWO (2) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS WAS DAMAGED WHICH PREVENTED THE CONNECTION TO CATHETER HUB. THIS WAS NOTICED WHILE CONNECTING DURING INTRAVENOUS PLACEMENT. 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 20126605 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT MALE PORTION OF THE LUER LOCK ADAPTER OF TWO (2) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS WAS DAMAGED WHICH PREVENTED THE CONNECTION TO CATHETER HUB. THIS WAS NOTICED WHILE CONNECTING DURING INTRAVENOUS PLACEMENT. 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 19983819 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT MALE PORTION OF THE LUER LOCK ADAPTER OF TWO (2) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS WAS DAMAGED WHICH PREVENTED THE CONNECTION TO CATHETER HUB. THIS WAS NOTICED WHILE CONNECTING DURING INTRAVENOUS PLACEMENT. 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 19983796 ↗
• MalfunctionNov 29, 2023

  UPON OPENING, HAIR WAS FOUND IN SEALED PRODUCT PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239313 ↗
• MalfunctionNov 21, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS BROKE RESULTING IN LEAK OF INTRAVENOUS (IV) SOLUTION; FURTHER DESCRIBED AS ¿BREAKS OFF AT THE HUB" THAT CONNECTS TO THE IV CATHETER "CAUSING THE IV TO LEAK" (NEAR TO THE T-CONNECTOR AND TUBING JUNCTION). THE LEAKS WERE DISCOVERED DURING UNSPECIFIED PROCESS STEPS. 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 18185722 ↗
• MalfunctionOct 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STOPPER OF FOUR (4) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS DISLODGED. THIS ISSUE WAS IDENTIFIED DURING A PROCEDURE. 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 15616160 ↗
• MalfunctionSep 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET SEPARATED. THE EVENT WAS FURTHER DESCRIBED AS; DURING PATIENT USE, "THE TOP OF THE PUNCTURE SITE CAME OFF WHILE DRAWING FROM AN ARTERIAL LINE". 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 15499794 ↗
• InjuryAug 25, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED WHILE ATTEMPTING TO GIVE A DOSE OF EPINEPHRINE DURING A PATIENT "CODE", THE RUBBER STOPPER OF AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET BECAME DISLODGED AND THE PATIENT DID NOT RECEIVE THE DOSE OF MEDICATION. THE "DOSE WAS REPEATED AND COMPRESSIONS WERE INITIATED." THE CAUSE OF THE DISLODGEMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 15297947 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921899. One submission often covers many models, so check the product and lot details in each record.

• Z-0646-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid
• Z-0643-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0654-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx ste
• Z-0656-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonp
• Z-0630-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites
• Z-0517-03 · Oct 17, 2002 · Terminated
  Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332; Baxter Healthcare Corporation, Deerfield, IL 60015; 200
• Z-0518-03 · Oct 17, 2002 · Terminated
  Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333; Baxter Healthcare Corporation, Deerfield, IL 60015; 200