CLEARLINK 2C8671Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00085412046334), received between Apr 16, 2018 and Sep 24, 2026 — classified as 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 reports).

2 other recalls cover devices cleared under the same FDA submission (K153158); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionNov 13, 2024Complete Blockage; No Flow; Complete Blockage; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET HAD NO SOLUTION FLOW. THE FILTER CHAMBER SEEMED BLOCKED. ONCE THE FILTER CHAMBER WAS FILLED AND EMPTIED, THE FILTER CHAMBER WOULD NOT REFILL. THIS OCCURRED DURING SETUP. 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 20674508 ↗
• MalfunctionOct 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS HAD WHITE DISCOLORATION OR A BLEMISH INSIDE THE TUBING, NEAR THE FILTER. SOME OF THE WHITE DISCOLORATION (SUBSTANCE) COULD BE SCRAPED OFF THE TUBING. THIS WAS OBSERVED WHEN RETRIEVING THE SETS FROM THE CASES, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403759 ↗
• MalfunctionOct 27, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS HAD FLOW ISSUES (NOT FURTHER SPECIFIED). THIS WAS DISCOVERED 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 18021565 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DURING A PATIENT INFUSION OF A VASOPRESSOR WITH TWO CLEARLINK SYSTEM EXTENSION SETS, THE PATIENT'S BLOOD PRESSURE INCREASED. IT WAS FURTHER REPORTED THAT WHEN THE LINE WAS PRIMED THE FILTER FILLS BUT EMPTIES OUT ONCE THEY START RUNNING THE INFUSION, WHICH AFFECTED THE VASOPRESSOR TITRATIONS. WHEN THE FILTER WAS NOTED TO BE EMPTY, A NEW FILTER WAS PRIMED AND REPLACED HOWEVER, THE SAME ISSUE OCCURRED WITH THE NEW FILTER. THE BLOOD PRESSURE NORMALIZED AFTER THE FILTER WAS REMOVED FROM THE LINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 16471809 ↗
• MalfunctionFeb 16, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM EXTENSION SET APPEARED CRACKED AND SUBSEQUENTLY LEAKED. AFTER THE SET WAS PRIMED, THE NURSE "WENT TO PUT THE TUBING INTO THE PUMP" AND OBSERVED "THE FILTER FILLED WITH AIR WHEN CLAMPED". THE NURSED NOTED THE LINE WAS LEAKING. THE SET WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386641 ↗
• InjuryMay 9, 2022Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT DURING PATIENT INFUSION OF LEVOPHED, PHENYLEPHRINE AND AMIODARONE WITH 3 UNITS OF CLEARLINK SYSTEM EXTENSION SETS, AN INADVERTENT BOLUS FROM THE EXTENSION FILTER WAS OBSERVED. THIS RESULTED IN THE PATIENT EXPERIENCING HYPERTENSION REPORTED AS ¿CAUSED THE BLOOD PRESSURE TO SKYROCKET¿. ACCORDING TO THE REPORTER, THE FILTER EMPTIED OUT ON ITS OWN. NO CONNECTION ISSUES WERE NOTED AND THE LINES WERE SETUP PROPERLY. AFTER THE "FILTERS WERE REMOVED, THE PATIENT'S BLOOD PRESSURE "EVENED OUT". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 14339574 ↗
• MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM THE INJECTION PORT. THE ISSUE WAS IDENTIFIED DURING A PATIENT INFUSION IN THE CANCER CENTER; FURTHER DESCRIBED AS ¿NOTED DURING THE NS (NORMAL SALINE) FLUSH PRIOR TO CHEMOTHERAPY ADMINISTRATION¿. 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 13715615 ↗
• MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WAS LEAKING COMING FROM THE FILTER AREA. THIS WAS OBSERVED AN INFUSION OF IRINOTECAN TO A PATIENT IN THE CANCER CENTER. 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 13715413 ↗
• MalfunctionJan 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED ONTO THE FLOOR FROM THE FILTER. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH KEYTRUDA. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158754 ↗
• MalfunctionJun 2, 2021Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET APPEARED TO HAVE AIR IN THE LINE. IT WAS FURTHER REPORTED, "DESPITE PROPER PRIMING OF THE FILTER, THE FILTER WAS COMPLETELY FILLED WITH AIR SHORTLY AFTER INFUSION STARTED". THE SET WAS FILLED WITH VELETRI. 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 11920266 ↗
• MalfunctionJun 1, 2021Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET APPEARED TO HAVE AIR IN THE LINE. IT WAS FURTHER REPORTED, "DESPITE PROPER PRIMING OF THE FILTER, THE FILTER WAS COMPLETELY FILLED WITH AIR SHORTLY AFTER INFUSION STARTED". THE SET WAS FILLED WITH REMODULIN. 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 11914378 ↗
• MalfunctionMay 21, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM EXTENSION SETS OVER-INFUSED DURING PATIENT USE. IT WAS FURTHER REPORTED THAT THE FILTER PORTION WAS EMPTYING OUT "WHILE INLINE AND CAUSING THE PATIENT TO GET BLOUSED WITH THE MEDICATION INFUSING". THE SET WAS USED WITH NOREPINEPHRINE 4MG/250ML. 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 11865430 ↗
• MalfunctionMay 19, 2021No Flow; No Flow

  IT WAS REPORTED THAT "MEDICATION WAS NOT PASSING OR FLOWING THROUGH" A CLEARLINK SYSTEM EXTENSION SET. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849620 ↗
• MalfunctionJan 6, 2021Backflow; Crack; Backflow; Crack

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM EXTENSION SET WAS CRACKED. IT WAS FURTHER REPORTED THERE WAS DIFFICULTY WITH THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) INFUSING; THE FLUID WAS BACKING UP. THIS WAS IDENTIFIED DURING USE OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11127106 ↗
• MalfunctionSep 9, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE IV TUBING OF A CLEARLINK SYSTEM EXTENSION SET POPPED OFF AT THE SCREW-ON COLLAR WHILE CONNECTED TO A NEONATE. THE EVENT WAS FURTHER REPORTED AS "THE COLLAR DOES NOT ENGAGE, JUST KEEPS SPINNING AROUND AND NOT TIGHTENING" WHICH LED TO A "SMALL AMOUNT OF BLOOD LOSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507365 ↗
• MalfunctionSep 5, 2019Improper or Incorrect Procedure or Method; Improper Flow or Infusion; Improper or Incorrect Procedure or Method; Improper Flow or Infusion

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET COMPLETELY EMPTIED. HOWEVER, UPON FURTHER CLARIFICATION IT WAS DETERMINED THE USER WAS NOT "INVERTING AND TAPPING" THE FILTER WHEN PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8967277 ↗
• MalfunctionSep 5, 2019Improper or Incorrect Procedure or Method; Improper Flow or Infusion; Improper or Incorrect Procedure or Method; Improper Flow or Infusion

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET COMPLETELY EMPTIED. HOWEVER, UPON FURTHER CLARIFICATION IT WAS DETERMINED THE USER WAS NOT "INVERTING AND TAPPING" THE FILTER WHEN PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8967274 ↗
• MalfunctionSep 5, 2019Improper or Incorrect Procedure or Method; Improper Flow or Infusion; Improper or Incorrect Procedure or Method; Improper Flow or Infusion

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET COMPLETELY EMPTIED. HOWEVER, UPON FURTHER CLARIFICATION IT WAS DETERMINED THE USER WAS NOT "INVERTING AND TAPPING" THE FILTER WHEN PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8967235 ↗
• MalfunctionSep 5, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET COMPLETELY EMPTIED. HOWEVER, UPON FURTHER CLARIFICATION IT WAS DETERMINED THE USER WAS NOT "INVERTING AND TAPPING" THE FILTER WHEN PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8967174 ↗
• MalfunctionAug 29, 2019Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE FLOW WAS UNABLE TO BE CONTROLLED ON AN UNKNOWN QUANTITY OF CLEARLINK SOLUTION ADMINISTRATION SETS WHICH RESULTED IN FREE FLOW OF MEDICATION. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947682 ↗
• MalfunctionAug 29, 2019Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE FLOW WAS UNABLE TO BE CONTROLLED ON AN UNKNOWN QUANTITY OF CLEARLINK SOLUTION ADMINISTRATION SETS WHICH RESULTED IN FREE FLOW OF MEDICATION. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8