CLEARLINKRecalls & reported problems across all models

We found 19 models of CLEARLINK by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 359 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2017 and Sep 28, 2026 — classified as 6 injuries, 353 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (193 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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, 2025Open, Classified

   IV sets may leak.

   Z-0200-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 29, 2025Open, Classified

   IV sets may leak.

   Z-0198-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Aug 29, 2025Open, Classified

   IV sets may leak.

   Z-0197-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Feb 8, 2024Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

   Z-1291-2024 · Root cause: Under Investigation by firm · 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 2R8401

  Set, administration, intravascular
  1 recall62 reports
• CLEARLINK 2H8603

  Set, administration, intravascular
  1 recall35 reports
• CLEARLINK 2H8671

  Set, administration, intravascular
  74 reports
• CLEARLINK 2C8632

  Set, administration, intravascular
  1 recall2 reports
• CLEARLINK 2C8610

  Set, administration, intravascular
  1 recall1 report
• CLEARLINK 2C8671

  Set, administration, intravascular
  39 reports
• CLEARLINK 2R8486

  Set, administration, intravascular
  38 reports
• CLEARLINK 2C8612

  Set, administration, intravascular
  33 reports
• CLEARLINK 2N8378

  Set, administration, intravascular
  22 reports
• CLEARLINK 1C8687

  Set, administration, intravascular
  10 reports
• CLEARLINK 2N8341

  Set, administration, intravascular
  10 reports
• CLEARLINK 2C8607

  Set, administration, intravascular
  9 reports
• CLEARLINK 2C8606

  Set, administration, intravascular
  7 reports
• CLEARLINK 2N8395

  Set, i.V. Fluid transfer
  5 reports
• CLEARLINK 2N8374

  Set, administration, intravascular
  4 reports
• CLEARLINK 2C8921

  Stopcock, i.V. Set
  4 reports
• CLEARLINK 2H8631

  Set, administration, intravascular
  2 reports
• CLEARLINK 2N8334

  Set, administration, intravascular
  1 report
• CLEARLINK 2N8377

  Set, administration, intravascular
  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 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918913 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  It was reported that a exhibited a bond separation at the Clearlink Y-site, resulting in leakage from the Total Parenteral Nutrition and lipid line and interruption of the Total Parenteral Nutrition infusion. This occurred during patient infusion. 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 50883069 ↗
• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  It was reported that a CLEARLINK System Extension Set contained black particulate matter inside the intravenous fluid path (in the tubing). The issue was noticed during setup after the set had been hung and primed. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766705 ↗
• MalfunctionJun 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP EXTENSION SET LEAKED FROM THE INFUSION LINE AT THE SITE OF THE MEDICATION FILTER. THE INFUSION WAS STOPPED IMMEDIATELY. THE UNSPECIFIED INFUSION PUMP INDICATED THAT APPROXIMATELY 7.9 ML OF MEDICATION WAS DELIVERED. THIS OCCURRED DURING INFUSION OF MOGAMULIZUMAB. 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 25593426 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET LEAKED "WHERE THE PROXIMAL PART OF THE Y SITE MEETS THE LINE". THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465017 ↗
• MalfunctionMay 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET LEAKED AT THE CLEARLINK INJECTION SITE; FURTHER DESCRIBED AS "LEAK AT THE BASE OF THE AIR CHAMBER ". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258595 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED BAXTER ACCESS SET LEAKED FROM AN UNSPECIFIED LOCATION DURING A TOTAL PARENTERAL NUTRITION (TPN) INFUSION. THE PATIENT BECAME ACUTELY AGITATED DESPITE FENTANYL TREATMENT, PROMPTING THE REGISTERED NURSE TO ASSESS THE INTRAVENOUS (IV) LINE, AT WHICH TIME LEAKAGE OF THE TPN WAS IDENTIFIED. THE TUBING WAS DEEMED UNRELIABLE AND DISCONTINUED, AND THE PROVIDER ORDERED DEXTROSE CONTAINING IV FLUIDS IN PLACE OF THE TPN. BLOOD GLUCOSE LEVELS WERE MONITORED, AND THE PATIENT WAS SUBSEQUENTLY FOUND TO BE HYPOGLYCEMIC AND REQUIRED A 10% DEXTROSE (D10) BOLUS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypoglycemia; Irritability

  MAUDE report 24973814 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET LEAKED DURING A PARENTERAL NUTRITION INFUSION. CUSTOMER INDICATED THAT THE LEAK WAS DUE TO "A PIN HOLE AT OR NEAR THE DRIP CHAMBER". 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 24915256 ↗
• MalfunctionApr 10, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN IV EXTENSION SET CRACKED AT THE CLEARLINK Y-SITE LUER, RESULTING IN A LEAK. THE EVENT OCCURRED DURING DOXURUBICIN INFUSION IN THE ACUTE CARE INPATIENT UNIT. 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 24844964 ↗
• InjuryApr 1, 2026Backflow; Crack

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET HAD AN ACTIVE BLEEDING AT THE PATIENT¿S PICC TRIPLE Y SITE (PRECISE SOURCE IS UNCLEAR), AS WELL AS LIPID AND BLOOD BLACKFLOW. THE IV LINE REPORTEDLY CRACKED AT THE FILTER THE PREIVOUS NIGHT, RESULTING IN BLEEDING WHILE THE LINE WAS OPEN; THE KETAMINE PUMP WAS REPLACED AT THAT TIME, AND NO FURTHER ISSUES OCCURRED WHEN THE FILTER WAS NOT IN USE. LINE CAPS WERE CHANGED AT 04:00 DURING BLOOD CULTURE COLLECTION WITHOUT PRIOR CONCERNS. THE PATIENT WAS LATER FOUND "SOAKED IN BLOOD", PROMPTING DISPOSAL OF THE TPN AND INITIATION OF NEW INFUSIONS. THE PICC ITSELF APPEARED STRUCTURALLY INTACT, AND NO PUMP ALARMS OCCURRED; THE DURATION OF TIME THE PATIENT WAS WITHOUT ANALGESIA IS UNKNOWN. THE FOLLOWING DAY, THERAPY WAS INITIATED USING A SPECTRUM IQ INFUSION PUMP. A 1.2 MICRON FILTER WAS ADDED TO ONE LIMB OF THE TRIPLE Y DUE TO COMPATIBILITY CONCERNS BETWEEN KETAMINE AND AMINO ACIDS. IMMEDIATELY AFTER FILTER PLACEMENT, LIPIDS WERE OBSERVED BACKFLOWING INTO THE KETAMINE SYRINGE LINE, AND BLOOD WAS BACKFLOWING FROM THE RED LUMEN; HOWEVER, BOTH LINES FLUSHED EASILY AND REMAINED PATENT. THE SPECTRUMP PUMP WAS SUBSEQUENTLY CHANGED, AFTER WHICH FLOW NORMAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24757875 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET LEAKED LIPIDS FROM THE Y-SITE PORT. THIS OCCURRED DURING LIPID INJECTABLE EMULSION (SMOF) TREATMENT. THE LEAK WAS NOTICED APPROXIMATELY 4.5 HOURS AFTER THE START OF INFUSION. 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 24701188 ↗
• MalfunctionMar 19, 2026

  PATIENT WAS RECEIVING TAXOL, NEEDED A FILTER ADDED TO THE LINE. WHEN ATTACHING THE ONE-LINK NEEDLELESS CONNECTOR ONTO THE FILTER, THE ONE-LINK KEPT TWISTING ON THE FILTER, NOT LUER-LOCKING INTO PLACE. IF YOU TWISTED IT ON, YOU COULD JUST PULL THE ONE-LINK OFF OF THE FILTER. THE LUER-LOCK OF THE FILTER APPEARS SHARP AND JAGGED. WRITER USED SAME ONE-LINK CAP AND TWISTED ONTO NEW FILTER WITH NO ISSUE, SO WRITER KNEW THIS FILTER WAS FAULTY. (B)(4). LOT (10) R26A07079.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637971 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO(2) CLEARLINK SYSTEM EXTENSION SETS LEAKED FROM THE END OF THE TUBING WHERE THE MICRON FILTER WAS ATTACHED. THE ISSUE WAS NOTICED DURING PATIENT INFUSION. THE DEVICE WAS REPLACED 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 24609103 ↗
• MalfunctionMar 11, 2026Fitting Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET WAS UNABLE TO CONNECT WITH AN ONELINK NEEDLELESS CONNECTOR. THE ISSUE WAS DESCRIBED AS THE ONELINK CONTINUOUSLY TWISTING ON THE FILTER AND NOT LUER LOCKING INTO PLACE. THE LUER LOCK OF THE FILTER APPEARED SHARP AND JAGGED. THIS OCCURRED DURING PATIENT INFUSION WITH JEMPERLI. THE DEVICE WAS REPLACED 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 24570752 ↗
• MalfunctionFeb 25, 2026Crack; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET EXPLODED AND RESULTED IN LEAKAGE. THE ISSUE WAS DESCRIBED AS "THE FILTER WAS JAMMED AND WOULD NOT ALLOW MEDICATION THROUGH THE FILTER. A SALINE FLUSH WAS THEN USED TO TRY TO FLUSH THROUGH THE FILTER AND THE FILTER EXPLODED." THIS OCCURRED DURING PRIMING FOR AN INFLIXIMAB INFUSION; HOWEVER, IT WAS UNSPECIFIED WHETHER THE PATIENT WAS CONNECTED. 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 24444830 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• ONE-LINK12 models · 638 reports · 1 recall
• 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