CLEARLINK/CONTINU-FLORecalls & reported problems across all models

We found 8 models of CLEARLINK/CONTINU-FLO by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 416 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2017 and Sep 24, 2026 — classified as 1 death, 5 injuries, 410 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (176 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CLEARLINK/CONTINU-FLO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0195-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0192-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Aug 8, 2025Class IIOpen, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

   Z-2594-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 12, 2019Class IIOpen, Classified

   Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

   Z-0793-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported CLEARLINK/CONTINU-FLO problems

CLEARLINK/CONTINU-FLO models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CLEARLINK/CONTINU-FLO 2C8519

  Set, administration, intravascular
  3 recalls1 death221 reports
• CLEARLINK/CONTINU-FLO 2C8571

  Set, administration, intravascular
  1 recall47 reports
• CLEARLINK/CONTINU-FLO 2H8519

  Set, administration, intravascular
  93 reports
• CLEARLINK/CONTINU-FLO 2H8537

  Set, administration, intravascular
  24 reports
• CLEARLINK/CONTINU-FLO 2C8546

  Set, administration, intravascular
  22 reports
• CLEARLINK/CONTINU-FLO 2C8548

  Set, administration, intravascular
  5 reports
• CLEARLINK/CONTINU-FLO 2C8515

  Set, administration, intravascular
  3 reports
• CLEARLINK/CONTINU-FLO 2H8546

  Set, administration, intravascular
  1 report

Recent CLEARLINK/CONTINU-FLO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  During evaluation of a CLEARLINK System CONTINU-FLO Solution Set, leakage was observed due to detachment of the tubing from the clearlink during pressure testing. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878515 ↗
• 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 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134226 ↗
• MalfunctionAug 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122613 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED FROM THE MOST PROXIMAL Y-SITE DURING AN IRON INFUSION. THE INFUSION WAS 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 25568048 ↗
• MalfunctionJun 11, 2026No Flow

  IT WAS REPORTED THAT FLUID DID NOT FLOW THROUGH THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS. THE ISSUE WAS DESCRIBED AS: FLUID REACHED THE END OF THE LINE, BUT DID NOT FLOW OUT. ONCE THE CAP WAS REMOVED, THE FLUID FLOWED. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469093 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A PERFORATION WAS NOTED IN THE SEAL AT THE ACCESS LUER ACTIVATED VALVE OF A CLEARLINK SYSTEM CONTINU FLO SOLUTION SET, RESULTING IN INTRAVENOUS FLUID LEAKING FROM THE TUBING ONTO THE FLOOR. THIS OCCURRED DURING PRIMING OF THE TUBING WITH LACTATED RINGER'S SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115839 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A "8MMX3MM HOLE" WAS FOUND IN THE TUBING OF A CONTINU-FLO SOLUTION SET RESULTING IN A LEAK. THE LOCATION OF THE HOLE WAS BETWEEN THE SECOND AND THIRD LUER LOCKS (CLEARLINK) RESULTING IN A LEAK. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060534 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET TUBING SEPARATED AT THE CLEARLINK Y-SITE. THE EVENT OCCURRED WHILE UNSCREWING THE LUER LOCK FROM THE IV LINE IN THE ICU. 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 25035436 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) CONTINU-FLO SOLUTION SETS SEPARATED AT THE Y-SITE. THIS OCCURRED 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 25035336 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED DURING USE OF A CLEARLINK CONTINU-FLO SOLUTION SET. THE SET WAS BEING USED WITH A BAXTER MICRON FILTER EXTENSION SET AND AN UNSPECIFIED INFUSION PUMP. TWO HOURS AFTER STARTING INFUSION, THE INFUSION PUMP ALERTED DOWNSTREAM OCCLUSION. THE TUBING WAS FOUND TO BE LEAKING FROM AN UNSPECIFIED LOCATION ONTO THE PATIENT¿S LAP. THE PATIENT WAS DISCONNECTED, THE MEDICATION BAG WAS SPIKED WITH NEW TUBING AND FILTER TUBING AND THE MEDICATION WAS RESTARTED. 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 24663065 ↗
• InjuryMar 20, 2026Audible Prompt/Feedback Problem

  IT WAS REPORTED A CLEARLINK CONTINU-FLO SOLUTION SET POTENTIALLY CAUSED A DOWNSTREAM OCCLUSION ALARM ON THE BAXTER PUMP DURING PATIENT CONTINUOUS IV INFUSION OF ESMOLOL AND HEPARIN. THE HEALTHCARE PROFESSIONAL CHECKED THE IV TUBING, FLUSHED THE PERIPHERAL IV LINE, AND ENSURED THAT NO CLAMPS OR KINKS WERE PRESENT. THE PUMP WAS RESTARTED AFTER EACH ASSESSMENT, BUT THE ALARM REOCCURRED WITHIN A FEW MINUTES. DURING THIS PERIOD, THE PATIENT BECAME TACHYCARDIC. NO ISSUES WERE NOTED WITH THE HEPARIN INFUSION, WHICH CONTINUED TO RUN WITHOUT INTERRUPTION THROUGH THE SAME IV LINE. CLINICIAN DECIDED TO REPLACE BOTH ESMOLOL INFUSION BAG, TUBING AND PUMP. ONCE DONE, THE PATIENT'S HEART RATE DECREASED BY 40 BEATS PER MINUTE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Tachycardia

  MAUDE report 24649186 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS RIPPED OR CUT WHEN IT WAS REMOVED FROM THE PACKAGING. HOWEVER, IT WAS NOT SPECIFIED IF PATIENT WAS INVOLVED. 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 24640861 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED NEAR THE PORT CLOSEST TO THE PATIENT. THIS WAS OBSERVED SHORTLY AFTER STARTING AN ANTIBIOTIC INFUSION. THE NURSE STOPPED THE INFUSION AND DISCONNECTED THE PATIENT. A NEW INFUSION WAS INITIATED TO PREVENT ANY MISSED MEDICATION DOSE. 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 24633955 ↗
• MalfunctionMar 12, 2026

  NURSE WAS PRIMING IV TUBING (CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET) 104 INCH 0.2 MICRON FILTER, WHEN TUBING SEPARATED AT DISTAL PORT SITE. TUBING WAS NOT UNDER TENSION TO CAUSE SEPARATION. TUBING REMOVED FROM IV BAG AND REPLACED WITH NEW TUBING SET. DID NOT REACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579377 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls