CLEARLINK 2C7461Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00085412049069), received between Dec 29, 2017 and Aug 18, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “No Flow” (12 reports).

12 other recalls cover devices cleared under the same FDA submission (K203609, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Discolored; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302885 ↗
• MalfunctionApr 20, 2026Material Twisted/Bent; No Flow

  IT WAS REPORTED THAT A SECONDARY MEDICATION SET TUBE HAD A KINK UNDER THE DRIP CHAMBER THAT DID NOT ALLOW THE DELIVERY OF THE MEDICATION. THE EVENT OCCURRED DURING PIPERACILLIN AND TAZOBACTAM INFUSION IN THE ONCOLOGY DEPARTMENT. THIS LED TO THE PUMP PULLING FROM PRIMARY BAG. 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 24931295 ↗
• MalfunctionFeb 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION OBSERVED IN THE TUBING OF A CLEARLINK SECONDARY MEDICATION SET. THE PM WAS DESCRIBED AS, ¿WHITE LIQUID FOUND INSIDE IV SECONDARY TUBING¿. THE ISSUE WAS DISCOVERED WHEN REMOVED FROM THE STERILE 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 24414775 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT A CLEARLINK SECONDARY MEDICATION SET WAS BROKEN AND THE TUBING DID NOT HAVE A CLAVE ATTACHED TO IT. THIS ISSUE WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THE 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 24403250 ↗
• MalfunctionFeb 17, 2026Break

  DURING EVALUATION OF A RETURNED CLEARLINK SECONDARY MEDICATION SET, IT WAS OBSERVED THAT THE SPIKE OF THE DRIP CHAMBER WAS BROKEN. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED 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 24366574 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT OF A CLEARLINK SYSTEM SECONDARY MEDICATION SET SEPARATED FROM END OF TUBING. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843787 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED ACCESS SET HAD LEAKAGE AT THE CONNECTION POINT. THIS OCCURRED DURING PATIENT INFUSION WITH AZITHROMYCIN (ABX) PRIOR TO "CS" (CESAREAN SECTION). THE ISSUE WAS FURTHER DESCRIBED AS, AN ADAPTER WAS USED TO CONNECT THE ABX TO AN UNSPECIFIED 250 ML BAG AND APPLIED PIGGYBACK TUBING TO CONNECT TO THE PRIMARY TUBING. HOWEVER, A LEAK WAS OBSERVED AT THE CONNECTION POINT, RESULTING IN LEAKAGE FROM ALL AROUND THE AREA. 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 22569873 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET LEAKED AT THE JUNCTION OF THE DRIP CHAMBER AND TUBING. THE EVENT WAS DISCOVERED WHILE SPIKING A BAG OF ROBAXIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108788 ↗
• MalfunctionSep 9, 2024Backflow; Backflow

  IT WAS REPORTED THAT THE BACK FLOW VALVE OF A CLEARLINK SYSTEM SECONDARY MEDICATION SET FAILED TO WORK. THE PRIMARY LINE WAS CLAMPED; HOWEVER, THE SECONDARY MEDICATION FLOWED INTO THE PRIMARY BAG OF FLUID 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 20176512 ↗
• MalfunctionDec 12, 2023Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD CRINKLES AND WERE NOT ALLOWING THE LIQUID TO FLOW THROUGH PROPERLY. 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 18311661 ↗
• MalfunctionDec 1, 2023Filling Problem; Material Twisted/Bent; Priming Problem; Filling Problem; Material Twisted/Bent; Priming Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD A CRINKLE AND DID NOT ALLOW THE LIQUID TO FLOW THROUGH PROPERLY. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP WHEN USING THE DEVICE. 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 18247703 ↗
• MalfunctionAug 25, 2023No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SECONDARY MEDICATION SETS HAD FLOW ISSUES. THIS EVENT WAS FURTHER DESCRIBED AS, ¿MEDICATION DID NOT INFUSE READILY¿ AND ¿BACKFLUSH CONTINUED TO BE SLUGGISH¿. THE PRIMARY TUBING WAS CLAMPED FOR THE MEDICATION TO INFUSE. 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 17624881 ↗
• MalfunctionAug 14, 2023No Flow; No Flow

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM SECONDARY MEDICATION SETS WOULD NOT FLOW. EQUASHIELDS WERE ATTACHED TO PRIMARY TUBING AND THE BACKFLUSH WAS NOT AS BRISK AS USUAL. THE CHEMOTHERAPY MEDICATION WAS ATTACHED TO THE PIGGYBACK TUBING, HOWEVER THE MEDICATION WOULD NOT DRIP. THE EQUASHIELDS WERE CHANGED BUT THIS DID NOT CHANGE THE BACKFLOW FLUSH. THE MEDICATION CONTINUED TO NOT DRIP. THE PRIMARY LINE HAD TO BE CLAMPED FOR THE MEDICATION TO INFUSE. THIS WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540725 ↗
• MalfunctionJun 6, 2023No Flow; No Flow

  IT WAS REPORTED THAT CHEMOTHERAPY WOULD NOT INFUSE WHEN A CLEARLINK SYSTEM SECONDARY MEDICATION SET WAS ATTACHED TO A PRIMARY LINE. THE SET UP WAS VERIFIED AS CORRECT. THIS WAS DISCOVERED DURING PATIENT INFUSION. A NEW BAG WAS PREPARED AND THE ISSUE 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 17075033 ↗
• MalfunctionMay 15, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT A CLEARLINK SECONDARY MEDICATION SET HAD MILKY LOOKING FLUID IN THE DRIP CHAMBER. THIS WAS DISCOVERED DURING PRIMING. WHEN THE NURSE BACK PRIMED THE LINE (CLEANSED THE PRIMARY LINE WITH ALCOHOL AND ALLOWED TO DRY, THEN CONNECTED THE DRY SECONDARY LINE AND OPENED SECONDARY LINE CLAMP TO ALLOW PRIMARY FLUID TO BACKFILL), THE NORMAL SALINE LIQUID CAME OUT MILKY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933995 ↗
• MalfunctionMay 12, 2023Infusion or Flow Problem

  PATIENT'S CHEMOTHERAPY WOULD NOT INFUSE WHEN ATTACHED TO PATIENT'S PRIMARY LINE. ATTEMPTS TO TROUBLESHOOT WERE COMPLETED TO NO AVAIL. SET-UP VERIFIED AS CORRECT. NEW BAG WAS PREPARED WHICH INFUSED WITHOUT ISSUE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918731 ↗
• MalfunctionMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET WAS LEAKING BELOW THE DRIP CHAMBER. THIS WAS IDENTIFIED WHEN PRIMING THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465000 ↗
• MalfunctionDec 12, 2022No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET WOULD NOT BACK FLOW AND THERE WAS DIFFICULTY INFUSING. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP, AFTER ATTACHING THE SET TO THE Y-SITE OF A PRIMARY SET ABOVE THE PUMP. 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 15965134 ↗
• MalfunctionDec 5, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN DISCONNECTING A CLEARLINK SYSTEM SECONDARY MEDICATION SET FROM AN UNSPECIFIED PRIMARY SET, THE TIP OF THE SECONDARY SET THAT WAS CONNECTED TO THE Y-SITE OF THE PRIMARY SET BROKE OFF WHICH RESULTED IN A LEAK OF NORMAL SALINE. THIS ISSUE OCCURRED DURING 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 15915590 ↗
• MalfunctionNov 23, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TUBE CONNECTOR OF A CLEARLINK SYSTEM SECONDARY MEDICATION SET WAS NOT FITTING, "SEEMED TO BE LARGER THAN NORMAL." THE NURSES COULD NOT GET THE SET TO BACKFLOW. THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15852131 ↗
• MalfunctionOct 21, 2022Filling Problem; Free or Unrestricted Flow; Improper Flow or Infusion; Filling Problem; Free or Unrestricted Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS WERE NOT FLOWING PROPERLY WHILE IN USE WITH AN IV INFUSION PUMP. THIS WAS FURTHER DESCRIBED AS ¿THE PRIMARY IV LINE WAS RUNNING AT THE SAME TIME AS THE SECONDARY ONE¿. IT WAS ALSO NOTED THAT THE SECONDARY MEDICATION HAD MORE THAN THE USUAL AMOUNT OF MEDICATION LEFT IN THE BAG AFTER THE IV PUMP HAD RUN ITS COURSE. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSIONS WITH UNSPECIFIED MEDICATIONS. 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 15654895 ↗
• MalfunctionOct 21, 2022Free or Unrestricted Flow; Improper Flow or Infusion; Free or Unrestricted Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET WOULD NOT FLOW PROPERLY DURING AN UNSPECIFIED INFUSION. THIS WAS FURTHER DESCRIBED AS ¿THERE WAS MINIMAL FLOW OF THE SECONDARY IV (INTRAVENOUS) AND THAT THE PRIMARY IV LINE WAS RUNNING AT THE SAME TIME AS THE SECONDARY ONE¿. THIS WAS IDENTIFIED WHILE TESTING WITH AN INFUSION PUMP. 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 15654608 ↗
• MalfunctionOct 12, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (AT LEAST TEN) OF CLEARLINK SYSTEM SECONDARY MEDICATION SETS DID NOT BACK FLOW. THE SETS WOULD FLOW WHEN PRIMING NOT CONNECTED TO THE MAIN LINE, HOWEVER ONCE CONNECTED TO THE PRIMARY LINE THE SECONDARY LINE WOULD NOT BACKFLOW. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587896 ↗
• MalfunctionAug 16, 2022Complete Blockage; Disconnection; Fluid/Blood Leak; Complete Blockage; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET AND A CLEARLINK SYSTEM SECONDARY MEDICATION SET WHICH RESULTED IN A BLOCKAGE AND LEAK OF SOLUTION. THE CONNECTION ISSUE WAS DESCRIBED AS, THE CONNECTOR AT THE END OF THE SECONDARY SET DOES NOT WORK WITH THE INTEGRATED NEEDLELESS CONNECTORS THAT ARE INSTALLED ON THE PRIMARY SET. WHEN ATTACHING THE SECONDARY TUBING TO THE NEEDLELESS CONNECTOR ON THE PRIMARY TUBING, THERE APPEARED TO BE A BLOCKAGE. WHEN THE TUBING WAS REMOVED FROM THE NEEDLELESS CONNECTOR, THE FLUID LEAKED OUT OF THE DISCONNECTED TUBING BECAUSE OF THE BACK PRESSURE. 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 15233296 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SECONDARY MEDICATION SET LEAKED AT THE BOTTOM OF THE CHAMBER. THE SET WAS USED WITH NORMAL SALINE. THIS ISSUE WAS OBSERVED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915393 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0194-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0192-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
• Z-0193-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-2594-2025 · Aug 8, 2025 · Open, Classified
  Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration s
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
• 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