CLEARLINK/CONTINU-FLO 2C6254Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00085412046303), received between Jan 5, 2018 and Oct 31, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K130245); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET TUBING CAME APART. THIS WAS OBSERVED 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 23442536 ↗
• MalfunctionAug 6, 2025Backflow; Fluid/Blood Leak; Detachment of Device or Device Component; Backflow; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET FELL APART AT THE AREA WHERE THE PORTS WERE CONNECTED WHICH RESULTED IN A PATIENT BLOOD BACKING UP AND EXTERNALLY LEAKING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿AREA WHERE THE PORTS WERE CONNECTED WERE NOT TIGHT AND HAD AN ISSUE WHERE THE TUBING FELL APART¿. 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 22727030 ↗
• MalfunctionApr 3, 2025No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE NOT FLOWING "EFFECTIVELY". THE ISSUE WAS NOTICED DURING THE PRE-OPERATIVE PROCESS, DURING PATIENT 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 21766797 ↗
• MalfunctionJan 6, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT ONE-HUNDRED-THIRTY-EIGHT (138) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD DAMAGED PRIMARY PACKAGING. THE EVENT WAS FURTHER DESCRIBED AS "PACKAGING IS DEFLATED, AND SOMETIMES THERE ARE NOTICEABLE SPLITS/LEAKS IN THE SEAMS. SOMETIMES, THE PACKAGING IS JUST VERY DEFLATED AND YOU CAN HEAR AN AIR LEAK". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087883 ↗
• MalfunctionOct 30, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF AN UNSPECIFIED QUANTITY OF CLEARLINK CONTINU-FLO SOLUTION SETS WERE DAMAGED. THE DAMAGED PACKAGING WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566598 ↗
• MalfunctionOct 30, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF AN UNSPECIFIED QUANTITY OF CLEARLINK CONTINU-FLO SOLUTION SETS WERE DAMAGED. THE DAMAGED PACKAGING WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566596 ↗
• MalfunctionOct 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE DAMAGED. THE PACKAGING WAS DEFLATED, AND THERE WERE HOLES IN THE SEAM OF THE PACKAGING. THE DAMAGED STERILE PACKAGING WAS DISCOVERED WHILE THE DEVICES WERE STILL IN THE PACKAGING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452700 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD A BROKEN LINE; A "SECTION OF THE TUBING IS NOT CONNECTED TO THE OTHER" (SEPARATED COMPONENTS). THIS WAS OBSERVED WHEN THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607388 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM ONE OF THE LUERS. THIS OCCURRED DURING PRIMING WITH 5% DEXTROSE AND 0.9% SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. THE SET WAS REPLACED AND THE ISSUE RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467272 ↗
• MalfunctionNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED MEDICATION DURING PRIMING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿LEAKING WAS HAPPENING FROM THOSE SITES WHERE THE STOP COCK CONNECTS IN¿; THE AREA WHERE THE DOUBLE STOPCOCK ATTACHES TO THE TUBING. NORMAL SALINE AND SEDATING MEDICATIONS (PROPOFOL AND UNSPECIFIED OTHER MEDICATIONS) RUNNING THROUGH THE SETS. 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 18178645 ↗
• MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY AT LEAST TWO (2) OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS SEPARATED AT THE MANIFOLD. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 16831692 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SEPARATED AT THE MANIFOLD. THE SEPARATION 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 16820172 ↗
• MalfunctionJul 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION WAS LEAKING. THE EVENT WAS FURTHER DESCRIBED AS, ¿BLOOD BACK UP AND FLUID LEAKING OUT OF LOWEST CLAVE PORT¿. THIS EVENT OCCURRED DURING 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 15089179 ↗
• MalfunctionJun 29, 2022Fluid/Blood Leak

  CLEARLINK SYSTEM - BAXTER: IV WAS NOT FUNCTIONING PROPERLY. THIS RN (REGISTERED NURSE) CHECKED POSITION OF TUBING AND NOTED BLOOD BACK UP AND FLUID LEAKING OUT OF LOWEST CLAVE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851188 ↗
• MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED INTRAVENOUS FLUID FROM THE TOP LUER LOCK VALVE. THIS WAS IDENTIFIED DURING PATIENT INFUSION. THE SET WAS REPLACED AND THE ISSUE WAS RESOLVED. 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 14434658 ↗
• MalfunctionMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE UPPER PORT. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 14346499 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak

  CALLED TO BEDSIDE BY PREOP RN FOR 2ND ASSESSMENT OF EQUIPMENT AND WITNESSED IV FLUID LEAKING FROM TOP LUER LOCK VALVE. CONFIRMED WITH STAFF THIS VALVE HAD NOT BEEN USED FOR ANY MEDICATION ADMINISTRATION. TUBING/FLUID DISCONTINUED AND REPLACED WITH NEW SET, NO LEAKING NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186399 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak

  IV TUBING BAXTER LOT #(10)DR22A05031 LEAKING FROM UPPER PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117745 ↗
• MalfunctionNov 10, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (STATED AS ¿APPROXIMATELY 5¿) OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING WHILE PATIENTS IN THE PAIN CARE CENTER WERE RECEIVING INFUSIONS. THIS WAS FURTHER DESCRIBED AS ¿WHERE THE STOPCOCK IS CONNECTED WAS NOT COMPLETELY TIGHTENED AND IS WHAT RESULTED IN THE LEAKING¿. 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 12790562 ↗
• MalfunctionSep 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET 4-WAY STOPCOCK EXTENSION SET LEAKED AT A STOP COCK CONNECTION SITE. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT FOR THERAPY WHEN IT WAS DISCOVERED THAT BLOOD WAS COMING FROM THE STOPCOCK AREA. IT WAS SPINNING AROUND AND UNABLE TO BE TIGHTENED. AS A RESULT, THE TUBING WAS CHANGED. 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 12557660 ↗
• MalfunctionJun 21, 2021Break

  CLEARLINK CONTINU-FLO SOLUTION SET ROLLER CLAMP BROKEN/FUSED. NO PATIENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031608 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD LEAKING ISSUES. IT WAS FURTHER REPORTED THAT THE LEAKS OCCURRED WHERE THE T-CONNECTOR ATTACHED TO THE ACTUAL IV CATHETER. THIS ISSUE WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10839909 ↗
• MalfunctionOct 1, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WAS "FALLING APART" RESULTING IN A LEAK DURING PATIENT INFUSION OF UNKNOWN SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616505 ↗
• MalfunctionSep 29, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS "FALLING APART" RESULTING IN A LEAK DURING PATIENT INFUSION OF UNKNOWN SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603431 ↗
• MalfunctionMar 3, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET 4-WAY STOPCOCK EXTENSION SET WAS NOT CONNECTED WELL IN THE MIDDLE WHERE THE STOPCOCK IS LOCATED. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT FOR THERAPY WHEN IT WAS DISCOVERED THAT THE TUBING HAD FALLEN APART FROM THE STOPCOCK WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781945 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2026 · Aug 29, 2025 · Open, Classified
  CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code