CLEARLINK/CONTINU-FLO 2H8519Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00085412048451), received between Apr 17, 2018 and May 19, 2025 — classified as 93 malfunctions.

The most frequently reported specific device problem is “Failure to Prime” (36 reports).

7 other recalls cover devices cleared under the same FDA submission (K961225); 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED ETOPOSIDE FROM AN UNSPECIFIED LOCATION. THE LINE APPEARED TO BE GOING BACK UP THE PRIMARY TO THE ¿ANTI REFLUX VALVE¿ AND POURING OUT THERE. THE SECONDARY LINE TO THE MAIN LINE WAS SECURED. THE INFUSION WAS IMMEDIATELY STOPPED. 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 22044287 ↗
• MalfunctionDec 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WAS LEAKING FROM BETWEEN THE TUBING AND Y-SITE CONNECTOR. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿CHEMO FLOW THROUGH THE Y JUNCTION OF THE SOLID-FLEXIBLE PORTION OF THE TUBING¿. THE ISSUE WAS IDENTIFIED DURING THE 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 15973636 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS; AFTER MEDICINE ADMINISTRATION, AIR ALARM WAS TRIGGERED. PUMP WAS OPENED AND SOLUTION LEAKAGE WAS EVIDENCED. RUPTURED LINE WAS EVIDENCED. THIS WAS IDENTIFIED DURING INFUSION PUMP WASHING WITH SALINE SOLUTION. DURING MEDICINE ADMINISTRATION NO ALARM WAS TRIGGERED, THEREFORE, THE MEDICINE WAS COMPLETELY ADMINISTERED. 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 14197092 ↗
• MalfunctionMar 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED FROM "THE TUBE". THE EVENT OCCURRED DURING PRIME. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793209 ↗
• MalfunctionJan 11, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET FELL APART AT THE PROXIMAL 'Y' SITE (CLEARLINK COMPONENT). THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THE SET WAS CONNECTED TO A LARGE VOLUME INFUSION PUMP RUNNING AT A LOW RATE. BLOOD BACKED UP TWO INCHES IN THE TUBING BUT DID NOT REACH THE BREAK IN THE TUBING. 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 13226981 ↗
• MalfunctionNov 9, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED. DURING PATIENT INFUSION WITH AN UNSPECIFIED MEDICATED SOLUTION VIA AN UNKNOWN PUMP, A CRACK WAS OBSERVED WHICH CAUSED A LEAK. 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 12780981 ↗
• MalfunctionSep 27, 2021No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT FLOW. THE EVENT WAS FURTHER DESCRIBED AS "DURING USE, IT WAS ATTEMPTED TO CONNECT MEDICINE IN "Y" BUT IT DID NOT ALLOW THE MEDICINE TO PASS THROUGH". 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 12533627 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE PROXIMAL NEEDLELESS CONNECTOR. IT WAS STATED THAT APPROXIMATELY 20ML UNSPECIFIED FLUID LEAKED. 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 12464117 ↗
• MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED. DURING AN UNSPECIFIED INFUSION AN UNKNOWN BAXTER INFUSION PUMP DISPLAYED AN ALARM OF ¿AIR IN THE SET¿, THE LEAK WAS THEN OBSERVED. FURTHERMORE, THE LEAK IS "WHY IT FILLED WITH AIR". THE LOCATION OF THE LEAK WAS NOT SPECIFIED. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 12037927 ↗
• MalfunctionFeb 17, 2021No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET DID NOT FLOW. IT WAS FURTHER REPORTED THAT THE SET WAS NOT DRIPPING SO THE VEIN IS NOT KVO (KEEP VEIN OPEN). THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11338697 ↗
• MalfunctionFeb 16, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS OVERINFUSED. IT WAS FURTHER REPORTED THAT ¿IT WAS ALL OPEN AND THEY WALKED AWAY FROM THE PATIENT AND CAME BACK TO AN EMPTY BAG¿. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED 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 11333997 ↗
• MalfunctionFeb 15, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS OVERINFUSED. IT WAS FURTHER REPORTED THAT ¿IT WAS ALL OPEN AND THEY WALKED AWAY FROM THE PATIENT AND CAME BACK TO AN EMPTY BAG¿. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11330702 ↗
• MalfunctionFeb 15, 2021No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT THE SET "ISNT DRIPPING SO THE VEIN ISNT KVO" (KEEP VEIN OPEN). THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH AN UNSPECIFIED SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11330700 ↗
• MalfunctionJan 23, 2021No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT FLOW; FURTHER DESCRIBED AS ¿THE MEDICINE DOES NOT FLOW COMPLETELY THROUGH THE DEVICE, IT ONLY ALLOWS TO FLOW UNTIL THE PART NUMBER 3¿. THIS ISSUE WAS IDENTIFIED AT AN UNSPECIFIED PROCESS STEP DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  MAUDE report 11220140 ↗
• MalfunctionNov 24, 2020No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT THE SOLUTION WOULD ONLY REACHED THE CHAMBER. THIS WAS IDENTIFIED DURING USE. 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 10896538 ↗
• MalfunctionOct 21, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME. IT WAS FURTHER REPORTED THE SOLUTION DID NOT FLOW THROUGH THE DEVICE ALTHOUGH PRESSURE WAS APPLIED. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10713313 ↗
• MalfunctionSep 14, 2020Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME. IT WAS FURTHER REPORTED THAT THE LINE BELOW THE DRIP CHAMBER WAS BLOCKED. THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10528532 ↗
• MalfunctionSep 11, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT ONE HUNDRED NINETEEN (119) CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS HAD ¿BLURRED LABELING PRINT¿. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10525868 ↗
• MalfunctionSep 9, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10511137 ↗
• MalfunctionSep 1, 2020No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT FLOW. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 10477008 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET PRESENTED LEAKAGE THROUGH THE LINE. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10432137 ↗
• MalfunctionJul 23, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME. THIS ISSUE WAS IDENTIFIED DURING PRIMING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10317058 ↗
• MalfunctionJul 23, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10314935 ↗
• MalfunctionJul 23, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT FLOW DUE TO AN OBSTRUCTION. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH 50 MG CISPLATIN. 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 10314498 ↗
• MalfunctionMar 25, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WOULD NOT PRIME. IT WAS FURTHER REPORTED THAT THE MEDICATION "DID NOT PASS THE FILTER." THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9878334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0794-2020 · Dec 12, 2019 · Open, Classified
  ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Pro
• Z-0793-2020 · Dec 12, 2019 · Open, Classified
  Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vas
• Z-0475-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2920-2011 · Jul 21, 2011 · Terminated
  Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-1152-03 · Jul 16, 2003 · Terminated
  Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3 injection sites, Male Luer Lock Adapter, catalog 2C6521; Baxter Healthcare Corporation, Deerf