CLEARLINKRecalls & reported problems across all models

We found 19 models of CLEARLINK by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 710 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2017 and Sep 30, 2026 — classified as 1 death, 1 injury, 707 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (470 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 still open.

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

CLEARLINK 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. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0203-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0199-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0191-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Aug 9, 2022Class ITerminated

   Firm noted an increase in customer reports of leaks.

   Z-1653-2022 · Root cause: Process design · Recall details · FDA record ↗

Most reported CLEARLINK problems

CLEARLINK models

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

• CLEARLINK 2R8858

  Set, administration, intravascular
  1 recall129 reports
• CLEARLINK 2C8750

  Set, blood transfusion
  176 reports
• CLEARLINK 2R8403

  Set, administration, intravascular
  1 recall125 reports
• CLEARLINK 2C8858

  Set, administration, intravascular
  80 reports
• CLEARLINK 2C8634

  Set, administration, intravascular
  1 recall9 reports
• CLEARLINK 2C8425

  Set, administration, intravascular
  1 recall5 reports
• CLEARLINK 2C7461

  Set, administration, intravascular
  49 reports
• CLEARLINK 4C8723

  Set, blood transfusion
  1 death30 reports
• CLEARLINK 2H8486

  Set, administration, intravascular
  29 reports
• CLEARLINK 2C8857

  Set, administration, intravascular
  18 reports
• CLEARLINK 2N8399

  Set, administration, intravascular
  15 reports
• CLEARLINK 2C8401

  Set, administration, intravascular
  13 reports
• CLEARLINK 2N8371

  Set, administration, intravascular
  11 reports
• CLEARLINK 2H8401

  Set, administration, intravascular
  11 reports
• CLEARLINK 2C8720

  Set, blood transfusion
  5 reports
• CLEARLINK 4H8723

  Set, blood transfusion
  2 reports
• CLEARLINK 2C8402

  Set, administration, intravascular
  1 report
• CLEARLINK 4C8714

  Set, blood transfusion
  1 report
• CLEARLINK 2C8751

  Set, blood transfusion
  1 report

Recent CLEARLINK adverse event reports

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

• MalfunctionSep 30, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941448 ↗
• MalfunctionSep 24, 2026Break

  During evaluation of a CLEARLINK System Y-Type Blood/Solution Set, the spike adapter was observed to be broken. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878518 ↗
• MalfunctionSep 16, 2026Obstruction of Flow; No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796424 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755839 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736287 ↗
• MalfunctionSep 8, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674027 ↗
• MalfunctionSep 8, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674024 ↗
• MalfunctionAug 18, 2026Material Discolored; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302885 ↗
• MalfunctionJun 18, 2026Device Alarm System

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF Y-TYPE BLOOD/SOLUTION SETS WITH STANDARD BLOOD FILTER GENERATED DOWNSTREAM OCCLUSION ALARMS. THE EVENTS WERE IDENTIFIED DURING INFUSION AT RATES ABOVED 899 ML/HOUR ON A NOVUM IQ LVP. 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 25553888 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED AT THE Y-SITE (CLEARLINK). THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. 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 25402565 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED AT THE Y SITE (CLEARLINK). 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 25391958 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED AT THE Y-SITE (CLEARLINK). 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 25368678 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak; Material Puncture/Hole; Failure to Disconnect

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET HAD HOLES IN THE TUBING, RESULTING IN LEAKAGE OF NORMAL SALINE. THE EVENT OCCURRED WHILE THE USER WAS PREPARING TO ADMINISTER A UNIT OF BLOOD. THE USER SPIKED THE NORMAL SALINE BAG AND THEN, THE BLOOD UNIT. DURING PRIMING WITH NORMAL SALINE, FLUID RAPIDLY LEAKED FROM THE TUBING ONTO THE FLOOR. UPON INSPECTION, HOLES WERE IDENTIFIED IN THE TUBING AT THE CLAMP SECTION ON BOTH THE NORMAL SALINE AND BLOOD LINES. THE USER ATTEMPTED TO SWITCH THE UNIT OF BLOOD TO A NEW TUBING; HOWEVER, WAS UNABLE TO REMOVE THE TUBING. DURING FURTHER INSPECTION, THE TUBING LOOKED ¿PERFORATED¿ AND AFTER MANIPULATION, THE TUBING RIPPED LARGER WITH A WHOLE CHUNK OF THE TUBING COMING OFF. A NEW BLOOD UNIT AND TUBING WOULD BE USED TO CONTINUE THE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209694 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOUR (04) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS SEPARATED AT THE INTERFACE BETWEEN THE WHITE SPIKE AND THE CLEAR TUBING DURING A BLOOD TRANSFUSION, RESULTING IN BLOOD SPILLAGE. THESE OCCURRED DURING SURGERY WITH ANESTHESIA. THE TUBING SETS WERE REPLACED, WHICH RESOLVED 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 25116125 ↗
• MalfunctionApr 29, 2026Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVES DISCONNECTED DURING IMAGING SCANS. THERE WERE ATTEMPTS TO TIGHTEN THE CONNECTIONS MULTIPLE TIMES WITHOUT SUCCESS. AS A RESULT, THE DEVICES WERE DISCONNECTED AND NEW EXTENSIONS CONNECTED TO CONTINUE THE PROCEDURES. 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 25034616 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls