CLEARLINK/CONTINU-FLO 2C8571Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00085412046327), received between Apr 24, 2018 and Aug 3, 2026 — classified as 1 injury, 46 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K153158); 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.

Recalls naming this device

1. Aug 29, 2025Open, Classified

   IV sets may leak.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122613 ↗
• 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 ↗
• MalfunctionMar 3, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM A CRACK PORT. THIS WAS OBSERVED DURING PATIENT INFUSION. THE DEVICE CONTAINED PEMBROLIZUMAB AND NORMAL SALINE. 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 24497317 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TEN (10) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED AT THE "Y PORT" (CLEARLINK) DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689176 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AT THE Y-SITE (CLEARLINK). THE ISSUE OCCURRED DURING PATIENT INFUSION OF NORMAL SALINE. THE DEVICE WAS REPLACED WITH A NEW SET TO RESOLVE THE ISSUE. 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 23528600 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE Y-SITE LUER LOCK. THE DEVICE CONTAINED CISPLATIN, AND A POWER INJECTOR WAS USED. 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 23503769 ↗
• MalfunctionNov 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED A CONTINU-FLO SOLUTION SET UNDER-INFUSED. ON THE DAY OF THE EVENT AT 01:00 DURING A TOTAL PARENTERAL NUTRITION INFUSION (TPN), THE CLINICIAN OBSERVED THERE WAS ¿TOO MUCH¿ TPN REMAINING IN THE BAG. THE UNSPECIFIED INFUSION PUMP WAS CHANGED TWICE. THE SOLUTION SET WAS FLUSHED; NO LEAKS WERE NOTED AND ALL CLAMPS UNLOCKED. THE PUMP WAS NOTED TO BE RUNNING AT A SLOWER RATE THAN THE PROGRAMMED RATE OF 253ML/HOUR. AT 06:00 ALLEGEDLY THERE SHOULD ONLY HAVE TWO HOURS LEFT OF THE INFUSION; HOWEVER, ¿HALF OF THE BAG¿ REMAINED. 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 23482839 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SPLICED INTO HALF. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE SET WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417640 ↗
• MalfunctionOct 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD PARTICULATE MATTER (PM) CONTAMINATION IN THE PORT. THE PM WAS DESCRIBED AS, ¿DIRTY PORT ¿ THE ¿HIGHEST¿ PORT IS DIRTY/APPEARS TO HAVE SOMETHING IN IT/NOT STERILE¿. THIS ISSUE WAS OBSERVED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367814 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AT THE "CHAMBER BOTTOM". THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069290 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE Y-SITE. 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 23069092 ↗
• MalfunctionAug 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM ONE OF THE PORTS. THE DEVICE CONTAINED CHEMO. THIS WAS OBSERVED 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 22864297 ↗
• MalfunctionAug 18, 2025Detachment 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 FROM THE DISTAL CLEARLINK PORT. THE PORT WAS UNGLUED. THIS WAS OBSERVED DURING PRIMING WITH NORMAL SALINE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833107 ↗
• MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING SEPARATED AT THE LUER LOCK SITE OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THE ISSUE WAS DISCOVERED DURING PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820183 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE LOWEST PORT. THE DEVICE CONTAINED ANTI-THYMOCYTE GLOBULIN. THIS WAS OBSERVED 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 22818099 ↗
• InjuryAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CONTINU-FLO SOLUTION SET LEAKED. AFTER APPROXIMATELY FIFTEEN MINUTES INTO AN UNSPECIFIED INFUSION THE PATIENT¿S SPOUSE OBSERVED A PUDDLE ON THE FLOOR. DURING INSPECTION THE LEAK WAS NOTED TO BE ORIGINATING FROM ¿THE DISTAL CLAVE.¿ ROUGHLY ¿20%¿ OF THE SOLUTION WAS LOST. THE TUBING WAS CHANGED AND REPRIMED. THE PATIENT RECEIVED THE REMAINDER OF THE INFUSION. THE SOLUTION WAS INFUSED VIA AN UNSPECIFIED BAXTER PUMP WITH A PERIPHERAL IV. THE RATE WAS 250ML/HOUR WITH A 250ML VOLUME TO BE INFUSED. REPORTEDLY THERE WAS ¿UNKNOWN SERIOUS OR IMPORTANT MEDICAL EVENTS.¿ NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22810279 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE CLEARLINK LUER VALVE. THIS OCCURRED DURING PATIENT INFUSION. THE DEVICE CONTAINED INFLECTRA. 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 22718256 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED, AND FLUID WAS COMING FROM THE STOPPER OF THE DISTAL Y-SITE. THE ISSUE OCCURRED DURING PATIENT INFUSION. THE ISSUE WAS FURTHER DESCRIBED AS THE DEVICE LEAKED AT THE TIP OF THE Y-SITE WHERE YOU CONNECT A SYRINGE. FOR ONE OF THE CASES, THE SET WAS IN USE FOR 30 MIN ON A PUMP AND USED HERCEPTIN. FOR THE REMAINING OCCASIONS THE SET WAS IN USE FOR APPROXIMATELY 5 MINUTES WITH SALINE AND FOR 2 HOURS WITH LEUCOVORIN RESPECTIVELY. 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 22700679 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET CAME DISCONNECTED AT THE DISTAL Y-SITE WHILE PRIMING THE TUBING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700091 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET CAME APART AT THE DISTAL CLEARLINK PORT/UNGLUED. THIS OCCURRED DURING PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671534 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET DISCONNECTED AT THE PORT CONNECTION. THIS WAS OBSERVED DURING PRIMING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347459 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE ROUND FILTER CONNECTION ON THE TUBING. THE DEVICE CONTAINED PRESSOR. THIS OCCURRED DURING THE 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 21884992 ↗
• MalfunctionApr 22, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS CRACKED IN THE MIDDLE OF THE TUBING WHICH RESULTED IN A LEAK. THE LEAK OCCURRED WHILE PRIMING INFLIXIMAB AT THE OUTPATIENT TREATMENT FACILITY. 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 21884728 ↗
• MalfunctionOct 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD WHITE DISCOLORATION OR A BLEMISH INSIDE THE TUBING, NEAR THE FILTER. SOME OF THE WHITE DISCOLORATION (SUBSTANCE) COULD BE SCRAPED OFF THE TUBING. THIS WAS OBSERVED WHEN RETRIEVING THE SETS FROM THE CASES, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403666 ↗
• MalfunctionAug 6, 2024Backflow; No Flow; Backflow; No Flow

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD BLOOD BACKFLOW AND MEDICATION THAT LAGGED AT THE END OF PATIENT INFUSION. NON-FILTER TUBING SETS WERE USED TO RESOLVE 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 19922856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2