INTERLINK 2N3379Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00085412004945), received between Jan 6, 2025 and Sep 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD STRESS LINES. THIS WAS OBSERVED DURING VISUAL INSPECTION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066668 ↗
• MalfunctionSep 15, 2025Crack; Crack

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD A CRACK ON THE UPPER PART OF THE PLASTIC CASING. THIS WAS OBSERVED OUT OF THE BOX PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058793 ↗
• MalfunctionSep 5, 2025Crack; Crack

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD STRESS LINES. THE ISSUE WAS FOUND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986525 ↗
• MalfunctionSep 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) INTERLINK SYSTEM INJECTION SITES WERE FOUND TO HAVE CRACKS ON THE UPPER PART OF THE PLASTIC CASING OF THE SEPTUM, AROUND THE PIERCING. THE CRACKS RESULTED IN LEAK. THE ISSUE WAS FOUND DURING SET-UP; HOWEVER, MEDICATION WAS NOT INVOLVED AT THIS STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983862 ↗
• MalfunctionSep 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) INTERLINK SYSTEM INJECTION SITES WERE FOUND TO HAVE CRACKS ON THE UPPER PART OF THE PLASTIC CASING OF THE SEPTUM AROUND THE PIERCING, WHICH RESULTED IN A LEAK. THE ISSUE WAS FOUND DURING SET-UP; HOWEVER, MEDICATION WAS NOT INVOLVED AT THIS STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983706 ↗
• MalfunctionJan 6, 2025No Flow; Incomplete or Inadequate Connection; No Flow; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE FLUID DID NOT FLOW THROUGH AN INTERLINK SYSTEM INJECTION SITE. THE ISSUE WAS FURTHER DESCRIBED AS, THE NEEDLE WAS UNABLE TO PIERCE THE INJECTION SITE WHICH LED TO NO FLOW. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082280 ↗

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-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-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-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-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-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-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-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-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-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-1102-05 · Jul 6, 2005 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation,

…and 11 more.