INTERLINK 2N3374Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412004907), received between Jan 10, 2019 and Aug 21, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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.

• MalfunctionAug 21, 2026Backflow; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383043 ↗
• MalfunctionOct 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED WHERE THE MICROCLAVE CAP WAS CONNECTED. THE ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940130 ↗
• MalfunctionOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SETS LEAKED WHERE IT CONNECTS TO THE MICROCLAVE CAP. THIS WAS DISCOVERED DURING PATIENT 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 17926660 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET LEAKED FROM THE FEMALE LUER CONNECTOR. THE SET WAS CONNECTED TO A NON-BAXTER SYRINGE. THE ISSUE WAS IDENTIFIED 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 17905499 ↗
• MalfunctionFeb 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SETS LEAKED. WHEN CONNECTING THE INTERLINK TO A NON-BAXTER CAP, LEAKS WERE OBSERVED AT THE CONNECTION SITE. THE CAPS AND EXTENSION SETS HAD TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11284876 ↗
• MalfunctionFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SET WAS LEAKING BETWEEN THE MALE LUER CONNECTION AND A NON-BAXTER FILTER. THIS EVENT WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700301 ↗
• MalfunctionJan 10, 2019Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT A LEAK WAS DISCOVERED BETWEEN THE CONNECTION OF AN INTERLINK SYSTEM CATHETER EXTENSION SET AND A NON-BAXTER REFILL KIT. THE LEAK WAS OBSERVED DURING ADMINISTRATION OF INTRATHECAL INJECTION TO A PATIENT. 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 8237119 ↗

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-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-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-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-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-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-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-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-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-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.