INTERLINK 2N3378Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412004938), received between Aug 16, 2021 and Jul 7, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

26 other recalls cover devices cleared under the same FDA submission (K925126); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT FOUR (4) INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SETS LEAKED. THE ISSUE OCCURRED WHEN INJECTING CONTRAST MEDIA DURING PATIENT USE. THE EVENT WAS FURTHER DESCRIBED AS WHEN ¿THE CLAMP REMOVED, A SLIGHT DEFORMITY APPEARS AT THE SITE THAT SEEMS TO CREATE A WEAK POINT IN THE TUBING¿; THE SETS RUPTURED RESULTING IN A LEAK. THE CONTRAST WAS CLEANED UP AND AN UNSPECIFIED QUANTITY OF SETS WERE REPLACED TO RESOLVE THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279877 ↗
• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED. WHEN THE TUBING WAS CLAMPED AND THEN THE CLAMP REMOVED, A SLIGHT DEFORMITY APPEARED AT THE SITE THAT CREATED A WEAK POINT IN THE TUBING. THE AREA RUPTURED DURING INJECTION OF CONTRAST MEDIA. THE CONTRAST MEDIA WAS CLEANED OFF THE EQUIPMENT AND 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 17203700 ↗
• MalfunctionMar 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED AT THE "FEMALE CONNECTOR BELOW CLAVE". THE ISSUE WAS IDENTIFIED 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 13686072 ↗
• MalfunctionFeb 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET WAS LEAKING FROM THE FEMALE CONNECTOR. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿LEAKING AT FEMALE CONNECTOR BELOW CLAVE¿. THIS 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 13571971 ↗
• MalfunctionSep 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING TESTING WITH A SALINE SYRINGE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434314 ↗
• MalfunctionAug 23, 2021Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED. IT WAS FURTHER REPORTED, THE LEAK WAS "AT THE POINT OF ATTACHMENT TO THE IV CATHETER HUB". IT WAS STATED THE DEVICE LEAKED BLOOD AND UNSPECIFIED FLUIDS; ALONG WITH, BACKFLOW OF BLOOD. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 12354711 ↗
• MalfunctionAug 16, 2021Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED. IT WAS FURTHER REPORTED, THE LEAK WAS "AT THE POINT OF ATTACHMENT TO THE IV CATHETER HUB". IT WAS FURTHER REPORTED THE DEVICE LEAKED BLOOD AND UNSPECIFIED FLUIDS; ALONG WITH, BACKFLOW OF BLOOD. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 12328020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925126. One submission often covers many models, so check the product and lot details in each record.

• Z-1269-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is ind
• Z-0471-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2837-2011 · Jul 6, 2011 · Terminated
  Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathw
• Z-0652-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F
• Z-0644-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcar
• 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-0648-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lo
• Z-0640-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F
• Z-0634-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer
• Z-0629-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a
• Z-0641-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstrea
• Z-0637-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock ad
• Z-0638-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter
• Z-1424-05 · Aug 3, 2005 · Terminated
  Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a mal
• Z-1099-05 · Jul 6, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerf

…and 11 more.