CLEARLINK/CONTINU-FLO 2H8537Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00085412080901), received between Sep 25, 2018 and Sep 22, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Insufficient Flow or Under Infusion

  It was reported that an unspecified quantity of CLEARLINK Non-DEHP Continu-Flo Solution Sets had infusion times approximately twice as long as expected. This 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 50850072 ↗
• MalfunctionAug 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE INJECTION PORT PROXIMAL TO THE PATIENT DURING INFUSION. THE EVENT WAS FURTHER DESCRIBED AS "LIQUID FLOWED OUT AS IF THE VALVE WAS DYSFUNCTIONAL". 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 20052402 ↗
• MalfunctionSep 20, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WAS UNABLE TO CONNECT AS THE CONNECTOR WAS UNABLE TO RETRACT. THIS WAS DISCOVERED DURING SET-UP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785267 ↗
• MalfunctionOct 7, 2022Fitting Problem; No Flow; Fitting Problem; No Flow

  IT WAS REPORTED THAT THE TOP PORT OF THREE (3) CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS WOULD NOT CONNECT TO THE LINE OF AN UNSPECIFIED QUANTITY OF IV (INTRAVENOUS) SECONDARY INFUSION SETS; FURTHER STATING ¿THE SETS WOULD NOT BACK PRIME OR FLOW¿. THE SECONDARY SETS WERE ¿RE-SET, RE-ESTABLISHED, CONNECTED AND RE-CONNECTED; HOWEVER, UNSUCCESSFUL¿. THIS WAS OBSERVED BEFORE PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567193 ↗
• MalfunctionJun 23, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM THE MIDDLE Y-PORT (CLEARLINK COMPONENT) OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS. 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 14794235 ↗
• MalfunctionMay 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET HAD A CRACK AND LEAK ¿AT THE DRIP CHAMBER/TUBING ATTACHMENT AREA¿. THIS 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 11808376 ↗
• MalfunctionApr 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. 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 11702160 ↗
• MalfunctionJul 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRIMARY LINE OF A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET WAS LEAKING AT THE PORT CLOSEST TO THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS NO MEDICATION ADDED. THIS ISSUE WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10264677 ↗
• MalfunctionJun 22, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT CONCURRENT FLOW WAS OBSERVED WITH A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET. IT WAS FURTHER REPORTED THAT IV ANTIBIOTIC WAS HUNG USING A BAXTER SECONDARY MEDICATION SET OFF OF A CONTINU-FLO SOLUTION SET USING A BAXTER PUMP. IT WAS FURTHER REPORTED THAT THE MEDICATION WAS SET TO RUN THROUGH THE SECONDARY SET BUT FLUID WAS INFUSING FROM BOTH PRIMARY BAG AND SECONDARY BAG. THE MEDICATION DID NOT INFUSE BECAUSE 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 Consequences Or Impact To Patient

  MAUDE report 10180905 ↗
• MalfunctionMay 28, 2020Backflow; Backflow

  IT WAS REPORTED THERE WAS BACKFLOW FLOW THROUGH A CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET THAT WAS CONNECTED TO AN UNSPECIFIED ACCESS SECONDARY SET. IT WAS FURTHER REPORTED THAT WITHIN 15 MINUTES OF THE START OF THE MEDICATION, THE SECONDARY SET WHICH CONTAINS A BAG OF NON-CYTOTOXIC MEDICATION PULLED INTO THE CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET. 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 10098638 ↗
• MalfunctionDec 13, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD A HOLE IN THE TUBING NEAR THE ROLLER CLAMP. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED WHEN THEY TRIED TO REMOVE THE TUBING FROM THE ROLLER CLAMP GUIDE. THIS ISSUE WAS IDENTIFIED AFTER 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 9469470 ↗
• MalfunctionDec 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS CUT IN TWO AT THE SLIDE CLAMP. THIS ISSUE WAS IDENTIFIED AFTER USE WHEN THE NURSE OPENED THE SLIDE CLAMP. THE PATIENT WAS NOT CONNECTED TO THE SET. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459963 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS WERE LEAKING ¿AT THE ANGIOCATH CONNECTING HUB¿. THIS ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEPS. 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 9306510 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS WERE LEAKING ¿AT THE ANGIOCATH CONNECTING HUB¿. THIS ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEPS. 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 9306506 ↗
• MalfunctionJul 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED. IT WAS FURTHER REPORTED THE PERIPHERAL INTRAVENOUS (IV) LINE WAS ESTABLISHED AND THE SET WAS PRIMED; NO LEAK WAS OBSERVED. AFTER THE SET WAS ATTACHED TO THE NON-BAXTER CATHETER, CONTINUOUS FLUID DROPLETS AT THE LUER ACTIVATED VALVE WAS OBSERVED ON THE SET. THE EVENT OCCURRED DURING PATIENT 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 8816725 ↗
• MalfunctionApr 29, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK CONTINU-FLO SOLUTION SETS WERE LEAKING OR HAD A CRACK (NOT SPECIFIED FURTHER). THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8561998 ↗
• MalfunctionMar 20, 2019Device Displays Incorrect Message; Material Deformation; Device Displays Incorrect Message; Material Deformation

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET COLLAPSED IN THE INFUSION PUMP WHICH RESULTED IN AN UPSTREAM OCCLUSION ALARM. THIS EVENT OCCURRED 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 8437712 ↗
• MalfunctionMar 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED FROM THE SECOND Y-SITE BELOW THE CLAMP. THE REPORTER STATED THAT THE LEAK OCCURRED AFTER A SALINE BAG WAS ATTACHED TO THE Y-SITE AND THE CLAMP WAS RELEASED. THIS OCCURRED DURING 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 8430771 ↗
• MalfunctionFeb 14, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBE OF A CLEARLINK CONTINU-FLO SOLUTION SET DETACHED FROM THE LUER VALVE CLOSEST TO THE PATIENT. THIS OCCURRED WHILE THE SET WAS BEING PRIMED WITH LACTATED RINGERS SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8341391 ↗
• MalfunctionFeb 14, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE VALVE OF A CLEARLINK CONTINU-FLO SOLUTION SET WAS DETACHED FROM THE TUBING. THIS WAS IDENTIFIED DURING PRIMING WITH SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8339412 ↗
• MalfunctionFeb 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD A BLOOD LEAK DURING INFUSION. THE REPORTER STATED THAT THE BLOOD WAS LEAKING FROM THE FIRST ACCESS LUER. 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 8339356 ↗
• MalfunctionFeb 13, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED DURING INFUSION. THE REPORTER STATED THAT THE PATIENT NOTICED A BLOOD LEAK. WHEN THE NURSE CHECKED THE SET, THEY NOTICED THAT THE TUBING HAD COME DETACHED FROM THE PORT. 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 8337402 ↗
• MalfunctionSep 25, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE SPIKES OF AN UNKNOWN QUANTITY OF CLEARLINK SETS WERE FOUND LOOSE (SEPARATED FROM THE TUBING) IN THE PACKAGE. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7907864 ↗
• MalfunctionSep 25, 2018No Flow; No Flow

  IT WAS REPORTED THAT AN UNKNOWN QUANTITY OF ACCESS-CONTINU-FLO SETS WOULD NOT FLOW WHEN ATTEMPTING TO PRIME THE TUBING. THE USER INVERTED THE FILTER AND TAPPED ALL CHECK VALVES. IT WOULD NOT FLOW EVEN AFTER THE SPIKE WAS PUSHED FURTHER, AND SALINE BAG AND CHAMBER SQUEEZED REPEATEDLY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7906187 ↗

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-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-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-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