CLEARLINK 2R8403Recalls & reported problems
Baxter Healthcare Corporation · CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Baxter ClearLink IV administration set is a tube set used to deliver intravenous solutions. Most of the 126 reports describe fluid leaking, often at the Y-site connector, and most say the patient was not affected. The reports include no deaths and no injuries. Reports rose to 9 in the last 12 months from 1 in the previous 12. There is 1 closed recall, begun in August 2022, over an increase in leak reports.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 125
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00085412656649), received between Jan 9, 2020 and Jun 4, 2026 — classified as 125 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (116 reports).
1 FDA recall record name this device's identifier.
7 other recalls cover devices cleared under the same FDA submission (K112893); 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.
Reports received per month
Recalls naming this device
- Aug 9, 2022Terminated
Firm noted an increase in customer reports of leaks.
Z-1653-2022 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak116
- Material Puncture/Hole5
- Break2
- Disconnection2
- Improper Flow or Infusion2
- Device Contamination with Chemical or Other Material1
- Failure to Disconnect1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions120
- No Patient Involvement3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205411 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205410 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205308 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205083 ↗MalfunctionJan 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THIS EVENT. 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 24193216 ↗MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP 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 22170343 ↗MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED DURING UNKNOWN PROCESS STEP. 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 18878303 ↗MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED DURING UNKNOWN PROCESS STEP. 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 18878302 ↗MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED DURING UNKNOWN PROCESS STEP. 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 18878284 ↗MalfunctionApr 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION ON THE TUBING OF A CLEARLINK SYSTEM SOLUTION SET. THE PM WAS FURTHER DESCRIBED AS, ¿A RED MARK ON A PRIMARY TUBING SET¿. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16827025 ↗MalfunctionMar 29, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE NON-BAXTER CHEMO LOCK WOULD NOT LOCK AND STAY ON THE DISTAL END OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS. THIS WAS DISCOVERED WHILE THE NURSING STAFF WAS CREATING A WORK FLOW PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16634759 ↗MalfunctionMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS LEAKING FROM THE FIRST CONNECTION PORT CLOSEST TO THE UNSPECIFIED INFUSION PUMP. THE SET WAS FILLED WITH UNSPECIFIED CHEMOTHERAPY SOLUTION AND THE VOLUME SPILLED OUT WAS APPROXIMATELY 25ML TO 50ML. THIS ISSUE WAS OBSERVED 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 16561430 ↗MalfunctionFeb 27, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM THE BOTTOM OF THE DRIP CHAMBER. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP. 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 16449907 ↗MalfunctionFeb 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM THE BOTTOM OF THE IV PUMP. THE TUBING WAS REMOVED FROM THE PUMP AND NOTED TO HAVE A SMALL SLIT TOWARDS THE BOTTOM OF THE INSERTED PART IN THE PUMP. THIS WAS IDENTIFIED DURING CHEMOTHERAPY 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 16354736 ↗MalfunctionJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED BELOW THE CHAMBER. THIS WAS OBSERVED AFTER THE NURSE HUNG A BAG OF ALIMTA. 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 16088269 ↗MalfunctionNov 23, 2022Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THERE WAS A CONNECTION ISSUE BETWEEN A SECONDARY CLEARLINK SYSTEM NON-DEHP SOLUTION SET AND THE Y-SITE OF A PRIMARY CLEARLINK SYSTEM - NON-DEHP SOLUTION SET. THIS OBSERVED AFTER THE PATIENT COMPLETED CHEMOTHERAPY TREATMENT. THE SECONDARY CHEMOTHERAPY TUBING WAS STUCK IN THE Y-SITE (CLEARLINK) OF THE PRIMARY TUBING; THE SETS WERE UNABLE TO DISCONNECT. 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 15857008 ↗MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM THE DISTAL Y-SITE CONNECTION. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED CHEMOTHERAPY DRUG. A DROP OF THE CHEMOTHERAPY DRUG GOT ON PATIENT'S HAND; HOWEVER, THE PATIENT WAS INSTRUCTED TO WASH THEIR HANDS THOROUGHLY. 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 15846708 ↗MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. ADDITIONALLY, THE EVENT OCCURRED AFTER THE SET HAD BEEN PRIMED WITH SALINE. THE SET WAS SENT TO THE UNIT; HOWEVER, THE LEAK WAS OBSERVED PRIOR TO PATIENT CONTACT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714774 ↗MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED WITH UNSPECIFIED LOCATION. THE ISSUE WAS IDENTIFIED DURING THE UNSPECIFIED LOCATION. 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 15712987 ↗MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET WAS LEAKING FROM BELOW THE DRIP CHAMBER. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 15708541 ↗MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET WAS LEAKING FROM BELOW THE DRIP CHAMBER. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 15700995 ↗MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET WAS LEAKING AT THE DRIP CHAMBER. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 15700655 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K112893. One submission often covers many models, so check the product and lot details in each record.
- Z-0197-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
- Z-0191-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
- Z-0199-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
- Z-0198-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
- Z-0190-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
- Z-0099-2014 · Sep 4, 2013 · TerminatedBaxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
- Z-1271-2013 · Mar 28, 2013 · TerminatedA) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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