CLEARLINK/CONTINU-FLO 2R8519Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00085412565682), received between Nov 14, 2019 and Jun 29, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 reports).

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

12 other recalls cover devices cleared under the same FDA submission (K180739, 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.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0201-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED DURING AN INFUSION OF INVESTIGATIONAL DRUG XALALURITAMIG. THE PATIENT REPORTEDLY NOTED FLUID DRIPPING FROM "THE SIDE OF THE PUMP". THE INFUSION WAS SUBSEQUENTLY STOPPED, AND THE AMOUNT INFUSED WAS RECORDED BY THE REGISTERED NURSE (RN). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659967 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP CONTINU-FLO SOLUTION SET DISCONNECTED FROM THE UPPER Y-SITE. THE EVENT OCCURRED WHILE FLUSHING THE OXALIPLATIN INFUSION LINE WITH DEXTROSE. WHEN THE REGISTERED NURSE WAS ADJUSTING THE DEXTROSE BAG ON THE IV POLE, THE INFUSION LINE SEPARATED AT THE UPPER Y-SITE. THIS LED TO THE SOLUTION LEAKING ON THE PATIENT. 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 24956607 ↗
• MalfunctionApr 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE CLEARLINK LUER. THE EVENT 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 24834601 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE 'CLEARLINK INJECTION SITES'. THE ISSUE OCCURRED DURING PATIENT 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 24811086 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET DETACHED AT THE CLEARLINK LUER. AT THE TIME OF THE EVENT, A "HUGE PUDDLE" AND PART OF THE IV SET WERE FOUND ON THE FLOOR. THE IV SET WAS NOT CONNECTED TO THE PATIENT. 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 24769714 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE Y-SITE (CLEARLINK) OF A NON-DEHP CONTINU-FLO SOLUTION SET POPPED OFF. THIS OCCURRED DURING PRIMING IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719979 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE DISTAL Y-SITE (CLEARLINK) OF A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET. 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 24308632 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET BECAME COMPLETELY DISCONNECTED FROM ONE OF THE PORTS (CLEARLINK). 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 24273890 ↗
• MalfunctionJan 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE CONNECTOR. THE DEVICE BACKFLOWED SALINE. 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 24228396 ↗
• MalfunctionJan 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM JUST BELOW THE FLUID DRIP CHAMBER WHERE THE TUBING CONNECTS TO THE CHAMBER. THIS WAS OBSERVED PRIOR TO CONNECTING AND STARTING CHEMOTHERAPY INFUSION. THE DEVICE CONTAINED 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 24226231 ↗
• MalfunctionJan 27, 2026No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD NO FLOW THROUGH THE Y-SITE. THIS WAS OBSERVED DURING PATIENT INFUSION. THE DEVICE CONTAINED IMMUNOGLOBIN (IVIG), AN IV PUMP WAS USED, AND A PERIPHERAL ACCESS 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 24195604 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET LEAKED FROM THE INJECTION SITE (CLEARLINK). THE ISSUE OCCURRED WITHIN THE FIRST FEW MINUTES AFTER THE PATIENT INFUSION STARTED. THE DEVICE WAS FILLED WITH D5W (DEXTROSE 5%) AND IT WAS USED IN CONJUNCTION WITH A NOVUM IQ 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 24119617 ↗
• MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET WAS SPLIT BETWEEN THE Y-SITES. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿TOTALLY DETACHED IN BETWEEN THE Y SITES¿. THIS WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728693 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET HAD A HOLE WHICH RESULTED IN A FLUID LEAK. THE EVENT OCCURRED DURING PREPARATION FOR ADMINISTRATION. THE DEVICE WAS FILLED WITH 200 MG PEMBROLIZUMAB. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547834 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET HAD SEVERED BETWEEN Y SITE CONNECTIONS. THIS EVENT OCCURRED WHILE PRIMING THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535488 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET WAS SPLIT BETWEEN THE Y-SITES. THIS WAS DISCOVERED DURING PRIMING WHEN IT WAS NOTICED THAT FLUID WAS DRIPPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510101 ↗
• MalfunctionSep 16, 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 NON-DEHP CONTINU-FLO SOLUTION SET GOT SEPARATED AT THE Y-SITE. THE DEVICE CONTAINED 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 23063236 ↗
• MalfunctionAug 7, 2025Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SETS HAD ETOPOSIDE CRYSTALLIZATION IN THE TUBING DESPITE THE DOSE BEING WITHIN RECOMMENDED CONCENTRATION PARAMETERS. THIS WAS ALSO NOTICED WHEN THE ETOPOSIDE WAS DILUTED FURTHER. THE ISSUE WAS OBSERVED 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 22745688 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET LEAKED FROM BELOW THE Y-SITE (CLEARLINK); THE Y-SITE HAD NOT BEEN ACCESSED AND THERE WAS A DYNAMIC LEAK. THIS WAS OBSERVED DURING INFUSION, AFTER HANGING THE MEDICATION. 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 22730991 ↗
• MalfunctionMay 14, 2025Volume Accuracy Problem; Material Twisted/Bent; Volume Accuracy Problem; Material Twisted/Bent

  IT WAS REPORTED THERE WERE FLOW RATE ACCURACY ISSUES WHILE USING AN UNSPECIFIED QUANTITY OF CLEARLINK NON-DEHP CONTINU-FLO SOLUTION SETS. THE FLOW RATE INACCURACIES WERE OBSERVED WHEN RUNNING AT A MAXIMUM RATE OF 1200 ML/HR; THERE WAS SIGNIFICANT RESIDUAL FLUID IN THE BAGS. THIS WAS IDENTIFIED DURING PATIENT INFUSIONS IN THE INTENSIVE CARE UNIT (ICU). THE RESIDUAL WAS NOTICED WITH PRIMARY OR SECONDARY INFUSIONS ON DIFFERENT PUMPS, DIFFERENT USERS, AND DIFFERENT MEDICATIONS. THIS EVENT WOULD OFTEN BE NOTICED FOLLOWING LENGTHY INFUSIONS RUNNING AT KEEP VEIN OPEN (KVO) 10 ML/HR FOLLOWED BY A FLOW RATE INCREASE TO 1200 ML/HR (OTHER TIMES USING THE BOLUS KEY). THE TUBING IN ALL CASES WERE LOADED CORRECTLY AND WERE OBSERVED TO HAVE SIGNIFICANT KINKS AT WHERE THE PINCH CLAMPS OCCLUDE THE LINE WITHIN THE PUMPING MECHANISM. THEY ALSO REPORTED THAT BY REPOSING THE TUBING BEFORE INCREASING THE RATE (OR AFTER BOLUS COMPLETE) RESULTED IN SIGNIFICANTLY IMPROVED ACCURACY. 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 22018861 ↗
• MalfunctionJul 16, 2024Crack; Crack

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET CRACKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752341 ↗
• MalfunctionJun 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET LEAKED FROM THE LUER LOCK PORT CLOSEST TO THE INTRAVENOUS (IV) BAG. THIS WAS OBSERVED DURING SETUP OF CHEMOTHERAPY 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 19576952 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP CONTINU-FLO SOLUTION SET WAS LEAKING. THE PATIENT WAS BLEEDING FROM THE CATHETER AND BLOOD WAS FOUND TO HAVE COME FROM THE CAP, INTO THE TUBE, LEAKING OUT. THIS OCCURRED TOWARDS THE END OF THE PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313235 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET LEAKED FROM THE MALE LUER ADAPTER. THIS ISSUE WAS FURTHER DESCRIBED AS, "LEAKING FROM THE END RIGHT ABOVE THE SPIROS CONNECTION" AND "LEAKING FROM ONE OF THE PORTS". THIS ISSUE OCCURRED WHILE PRIMING PRIOR TO PATIENT USE AND THE SET DID NOT MAKE IT OUT THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895242 ↗
• MalfunctionFeb 1, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SETS LEAKED DEXTROSE DURING PATIENT INFUSION. THE SOLUTION LEAKED OUT WHERE THE TUBING DISCONNECTED (NOT FURTHER SPECIFIED). 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 18623973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180739, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0203-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-i
• Z-0202-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
• Z-1009-2025 · Dec 20, 2024 · Open, Classified
  Baxter Solution Set with Duo-Vent Spike, REF 2R8404
• Z-1010-2025 · Dec 20, 2024 · Open, Classified
  Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
• Z-1291-2024 · Feb 8, 2024 · Open, Classified
  CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
• 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