INTERLINK 2N3339Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00085412004747), received between Jul 16, 2018 and Sep 7, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Disconnection; Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50651298 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM T-CONNECTOR EXTENSION SETS LEAKED AT THE SYRINGE CONNECTION SIDE. THERE WAS A HOLE IN THE TUBING/CONNECTION. THIS WAS OBSERVED UPON INJECTION. 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 22074357 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT TWO (2) NON-DEHP T-CONNECTOR EXTENSION SETS WERE LOOSE AND LEAKED. THIS WAS OBSERVED DURING A MRI PROCEDURE ON TWO (2) DIFFERENT PATIENTS WHERE PROPOFOL WAS ADMINISTERED. THE LOCATION OF THE LEAK WAS BETWEEN THE EXTENSION SETS AND INTRAVENOUS (IV) CATHETERS. 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 22038260 ↗
• MalfunctionDec 4, 2024Crack; Crack

  IT WAS REPORTED THAT THE T-CONNECTOR OF AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET CRACKED. THIS OCCURRED 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 20843594 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET LEAKED FROM A TINY HOLE IN THE T-CONNECTOR. THE NURSE STOPPED THE TPN (TOTAL PARENTERAL NUTRITION), AND THE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS CLAMPED. THE BEDSIDE NURSE CHANGED THE T-CONNECTOR. THIS 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 20663247 ↗
• InjuryNov 11, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET LEAKED DUE TO A HOLE IN THE LINE. DURING PATIENT INFUSION WITH TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, BLOOD WAS OBSERVED "BACKING OUT OF THE PICC LINE AND SEEPING OUT OF THE T-CONNECTOR". THE LEAK OCCURRED FOR AN UNKNOWN AMOUNT OF TIME. THE NURSE THEN CHECKED THE PATIENT¿S BLOOD SUGAR, AND IT WAS FOUND TO BE "28" WITH PATIENT "ALERT AND ACTIVE". AN INTRAVENOUS LINE WAS ATTEMPTED, AND THE T-CONNECTOR WAS CHANGED. THE PICC LINE WAS FLUSHED WITH NO LEAKS NOTED AND GOOD BLOOD RETURN. D10 BOLUS WAS INITIATED THROUGH THE PICC LINE AND ORAL GEL GLUCOSE ADMINISTERED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

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

  MAUDE report 20659406 ↗
• MalfunctionNov 8, 2024Crack; Crack

  IT WAS REPORTED THAT AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET HAD A CRACK. THIS WAS FURTHER DESCRIBED AS ¿CRACK IN THE 8 FR MINI PIGTAIL DRAIN AT THE CONNECTION TO THE T-CONNECTOR¿. 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 20644733 ↗
• MalfunctionOct 18, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SETS DISCONNECTED FROM THE PATIENT DURING USE RESULTING IN BLOOD LOSS. TO RESOLVE THE EVENT, THE SETS WERE REPLACED. 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 20482965 ↗
• MalfunctionMay 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPLIT SEPTUM/INTERLINK (RUBBER PIECE) OF AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET CAME OUT FROM THE CONNECTOR HOUSING. THIS WAS OBSERVED WHILE THE SET WAS ATTACHED TO A PATIENT'S INTRAVENOUS AND WHILE BEING ACCESSED USING A PLASTIC NEEDLE. 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 14341413 ↗
• MalfunctionMar 10, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET LEAKED WITH UNSPECIFIED FLUIDS AT THE FEMALE CONNECTOR ON THE END OF THE T CONNECTOR. IT WAS FURTHER REPORTED THAT THERE WAS A CRACK ALL THE WAY DOWN THE HUB. THIS ISSUE WAS IDENTIFIED WHILE CONNECTING THE FLUIDS TO THE PATIENT. 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 11455095 ↗
• MalfunctionMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET WAS LEAKING FROM THE JUNCTION OF THE T-PIECE HARD PLASTIC AND THE SOFT TUBING. THIS ISSUE WAS IDENTIFIED DURING FLUSHING OF THE PERIPHERAL INTRAVENOUS LINE (PIV). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422859 ↗
• MalfunctionNov 15, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR WAS OBSERVED IN THE LINE OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM T-CONNECTOR EXTENSION SETS; FURTHER DESCRIBED AS ¿WHEN PRIMED WITH FLUIDS AFTER ABOUT 5 TO 10 MINUTES OF SITTING PRIMED, THE EXTENSION TUBING WAS FULL OF AIR¿. THIS WAS IDENTIFIED PRIOR TO USE ON PEDIATRIC PATIENTS. IT WAS STATED, THE STAFF WOULD OBSERVE THE ISSUE PRIOR TO USE, RE-PRIME AND THEN AFTER ABOUT 10 MINUTES, THE TUBING WOULD FILL WITH AIR AGAIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9331614 ↗
• MalfunctionOct 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET WAS LEAKING FROM THE T-CONNECTOR AT THE POINT WHERE THE EXTENSION TUBING MEETS THE PORT. THE LEAK WAS DISCOVERED DURING USE. THIS ISSUE WAS RESOLVED BY EXCHANGING THE SET FOR A NEW ONE. 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 7922354 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED THAT AN INTERLINK T-CONNECTOR EXTENSION SET BROKE DURING INFUSION. THE REPORTER INDICATED THAT THE PATIENT BROKE THE SET. THE SET HAD BEEN ATTACHED TO AN IV CATHETER. THE SET WAS REPLACED TO RESOLVE THE ISSUE. 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 7692285 ↗

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-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-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-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-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-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-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
• 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