ONE-LINKRecalls & reported problems across all models

We found 12 models of ONE-LINK by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 638 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2017 and Sep 30, 2026 — classified as 12 injuries, 626 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (243 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ONE-LINK recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 21, 2020Terminated

   There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

   Z-1102-2021 · Root cause: Process design · Recall details · FDA record ↗

Most reported ONE-LINK problems

ONE-LINK models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ONE-LINK 7N8301

  Set, administration, intravascular
  156 reports
• ONE-LINK 7N8399

  Set, administration, intravascular
  120 reports
• ONE-LINK 7N8300

  Set, administration, intravascular
  120 reports
• ONE-LINK 7N8391

  Set, administration, intravascular
  62 reports
• ONE-LINK 7N8370K

  Set, administration, intravascular
  1 recall6 reports
• ONE-LINK 7N8390

  Set, administration, intravascular
  54 reports
• ONE-LINK 7N8378

  Set, administration, intravascular
  35 reports
• ONE-LINK 7N8371

  Set, administration, intravascular
  34 reports
• ONE-LINK 7N8377

  Set, administration, intravascular
  23 reports
• ONE-LINK 7N8310

  Set, administration, intravascular
  18 reports
• ONE-LINK 7N8332K

  Set, administration, intravascular
  6 reports
• ONE-LINK 7N8376K

  Set, administration, intravascular
  4 reports

Recent ONE-LINK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954831 ↗
• MalfunctionSep 30, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954830 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926069 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926068 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926028 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925974 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925968 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925967 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923571 ↗
• MalfunctionSep 25, 2026Material Rupture

  It was reported that five (5) Non-DEHP Standard Bore Catheter Extension Sets fractured during infusion of intravenous contrast for computed tomography (CT) scans. 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 50900318 ↗
• MalfunctionSep 24, 2026No Flow

  It was reported that there was no fluid flow through a ONE-LINK Extension Set while connected to the patient. The extension set was connected to a non Baxter catheter and a Continue flo solution set during this event. The set was primed with either Lactated Ringers or normal saline. 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 50882930 ↗
• MalfunctionSep 15, 2026Backflow; Fracture

  It was reported that a Non-DEHP Standard Bore Catheter Extension Set exhibited a crack on its luer lock adapter. This occurred during use while connected to the patient. The reporter stated that the luer connection point did not slide properly due to the broken component, resulting is blood backflow. No blood loss was reported. 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 50773253 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  It was reported that a One-Link Non-DEHP Microbore Catheter Extension Set leaked at the intravenous connection during patient infusion of atezolizumab. The connector was reported to be securely connected prior to infusion; however, the connector became loose during use. The infusion was stopped and the line was reassessed and secured to resolve the issue. 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 50766655 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak; Fitting Problem

  It was reported that a One-Link Non-DEHP Microbore Catheter Extension Set could not be attached to an intravenous catheter and leaked when flushed with Sodium Chloride. This occurred during preparation and flushing prior to intravenous catheter insertion. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766361 ↗
• MalfunctionSep 14, 2026No Flow

  It was reported that a Non-DEHP Y-Type Microbore Catheter Extension Set exhibited no flow. The process step at which the issue occurred was not specified. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758647 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• CLEARLINK19 models · 359 reports · 4 recalls
• INTRAVIA7 models · 455 reports
• CLEARLINK/DUO-VENT3 models · 150 reports
• INTERLINK17 models · 129 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports
• PrismaSATE2 models · 1 reports · 1 recall