CLEARLINK 2H8671Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00085412080956), received between Mar 6, 2018 and Jun 23, 2026 — classified as 1 injury, 73 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (37 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP EXTENSION SET LEAKED FROM THE INFUSION LINE AT THE SITE OF THE MEDICATION FILTER. THE INFUSION WAS STOPPED IMMEDIATELY. THE UNSPECIFIED INFUSION PUMP INDICATED THAT APPROXIMATELY 7.9 ML OF MEDICATION WAS DELIVERED. THIS OCCURRED DURING INFUSION OF MOGAMULIZUMAB. 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 25593426 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET LEAKED "WHERE THE PROXIMAL PART OF THE Y SITE MEETS THE LINE". THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465017 ↗
• MalfunctionMar 19, 2026

  PATIENT WAS RECEIVING TAXOL, NEEDED A FILTER ADDED TO THE LINE. WHEN ATTACHING THE ONE-LINK NEEDLELESS CONNECTOR ONTO THE FILTER, THE ONE-LINK KEPT TWISTING ON THE FILTER, NOT LUER-LOCKING INTO PLACE. IF YOU TWISTED IT ON, YOU COULD JUST PULL THE ONE-LINK OFF OF THE FILTER. THE LUER-LOCK OF THE FILTER APPEARS SHARP AND JAGGED. WRITER USED SAME ONE-LINK CAP AND TWISTED ONTO NEW FILTER WITH NO ISSUE, SO WRITER KNEW THIS FILTER WAS FAULTY. (B)(4). LOT (10) R26A07079.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637971 ↗
• MalfunctionMar 11, 2026Fitting Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET WAS UNABLE TO CONNECT WITH AN ONELINK NEEDLELESS CONNECTOR. THE ISSUE WAS DESCRIBED AS THE ONELINK CONTINUOUSLY TWISTING ON THE FILTER AND NOT LUER LOCKING INTO PLACE. THE LUER LOCK OF THE FILTER APPEARED SHARP AND JAGGED. THIS OCCURRED DURING PATIENT INFUSION WITH JEMPERLI. THE DEVICE WAS REPLACED 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 24570752 ↗
• MalfunctionFeb 13, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP EXTENSION SET ¿BROKE AT THE TOP OF THE STRETCHY SECTION THAT GOES INTO THE PUMP¿ WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED WHILE PRIMING THE SET WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338979 ↗
• MalfunctionFeb 13, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON DEHP EXTENSION SETS (WITH FILTER) HAD AIR IN LINE WHILE BEING USED WITH ONE LINK NON DEHP STANDARD BORE CATHETER EXTENSION SETS. THE ISSUE WAS DESCRIBED AS, THE FILTER WAS PRIMED USING A SYRINGE, AND AFTER PRIMING, A ONE LINK NEEDLE FREE IV CONNECTOR WAS ATTACHED TO THE PROXIMAL END JUST ABOVE THE FILTER SO THE ASSEMBLY COULD BE ACCESSED SIMILARLY TO A SALINE WELL OR HEPARIN LOCK. 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 24337616 ↗
• MalfunctionFeb 10, 2026

  PATIENT WAS RECEIVING JEMPERLI, NEEDED A FILTER ADDED TO THE LINE. WHEN ATTACHING THE ONE-LINK NEEDLELESS CONNECTOR ONTO THE FILTER, THE ONE-LINK KEPT TWISTING ON THE FILTER, NOT LUER-LOCKING INTO PLACE. IF YOU TWISTED IT ON, YOU COULD JUST PULL THE ONE-LINK OFF OF THE FILTER. THE LUER-LOCK OF THE FILTER APPEARS SHARP AND JAGGED. WRITER USED SAME ONE-LINK CAP AND TWISTED ONTO NEW FILTER WITH NO ISSUE, SO WRITER KNEW THIS FILTER WAS FAULTY. (B)(4), LOT (10) R25K130310.

  Patient problems: Insufficient Information

  MAUDE report 24303845 ↗
• MalfunctionFeb 9, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP EXTENSION SET WAS CRACKED WHICH RESULTED IN A FLUID LEAK. THE PATIENT WAS CONNECTED FOR A LETERMOVIR INFUSION 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 24292641 ↗
• MalfunctionJan 21, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP EXTENSION SETS BROKE AT THE CONNECTION POINT DURING IMMUNOTHERAPY INFUSION (NIVOLUMAB) AND MEDICATION SPILLED. THE EVENT WAS FURTHER DESCRIBED AS 'DISCONNECTION OF CONNECTABLE COMPONENTS/CONNECTED PRODUCTS'. 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 24137145 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM NON-DEHP EXTENSION SETS LEAKED FROM THE FILTER. THE LOCATION OF THE LEAK WAS FURTHER DESCRIBED AS "BELOW THE FILTER". THE ISSUE WAS OBSERVED DURING PRIMING WITH CHEMOTHERAPY MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995003 ↗
• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE Y-SITE (CLEARLINK) OF A NON-DEHP EXTENSION SET LEAKED AN UNSPECIFIED AMOUNT. THIS WAS OBSERVED DURING PATIENT INFUSION WITH CHEMOTHERAPY AGENTS, WHILE THE NURSE WAS ATTEMPTING TO FLUSH THE LINE WITH SALINE. AFTER MOVING THE PATIENT, IT WAS NOTED THAT THE PILLOWCASE WAS DAMP UNDER THE PATIENT¿S ARM. 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 23950597 ↗
• MalfunctionDec 3, 2025Crack; Loose or Intermittent Connection; Crack; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE MALE LUER LOCK ADAPTER OF A CLEARLINK NON-DEHP EXTENSION SET CRACKED WHEN IT WAS CONNECTED TO THE PATIENT¿S CATHETER. THIS ISSUE OCCURRED WHEN THE PATIENT WAS CONNECTED TO A TPN (TOTAL PARENTERAL NUTRITION) INFUSION. WHEN CHECKING THE SITE OF THE PATIENT¿S CATHETER, IT WAS DISCOVERED THAT THE MALE LUER LOCK ADAPTER WAS CRACKED AND LOOSENED FROM THE CAP ON THE CATHETER BUT WAS NOT DISCONNECTED. 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 23709287 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK NON-DEHP EXTENSION SET HAD A BROKEN MEMBRANE. THIS ISSUE WAS DISCOVERED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908238 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS LEAKED AT THE CONNECTION TO CONTINU-FLO SOLUTION SETS. THE LEAK WAS OBSERVED BETWEEN THE FILTER EXTENSION SET AND THE MALE TUBING COMPONENT (MALE LUER) OF THE SOLUTION SETS. THIS WAS OBSERVED DURING SETUP IN THE PHARMACY. WHEN THE SETS WERE CONNECTED, THE CONNECTION APPEARED TO "NOT BE SEALING PROPERLY". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446241 ↗
• MalfunctionJun 6, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM ONE OF THE Y-SITES WHILE BEING USED WITH A CLEARLINK SYSTEM NON-DEHP EXTENSION SET. THIS OCCURRED DURING A PATIENT INFUSION OF AMIODARONE AT A RATE OF 33 ML/HR, WHICH HAD BEEN RUNNING FOR LESS THAN SIX HOURS. THE NURSE OBSERVED A PUDDLE OF FLUID UNDER THE INTRAVENOUS (IV) POLE. THE SET WAS LEAKING FROM THE FIRST PORT DOWNSTREAM FROM NOVUM IQ LARGE VOLUME PUMP. ADDITIONALLY, AS THE PATIENT ARM WAS EXTENDED, THE NURSE NOTICED BLOOD BACKING UP FROM THE SITE OF INSERTION TOWARD THE FILTER EXTENSION SET. 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 22161789 ↗
• MalfunctionMay 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET HAD A HOLE INSIDE OF THE FILTER. THE EVENT WAS OBSERVED BEFORE PRIMING. A NEW SET WAS USED TO CONTINUE WITH THE SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967885 ↗
• MalfunctionApr 9, 2025Break; Break

  IT WAS REPORTED THAT THE MICRON FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET HAD A BROKEN MEMBRANE. THIS ISSUE WAS DISCOVERED WHILE COMPOUNDING A DRUG DOSE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809952 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING PATIENT INFUSION WITH LECANEMAB 1002 MG IN 250 ML NORMAL SALINE. THE UNSPECIFIED BAG WAS REPLACED 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 21472305 ↗
• MalfunctionFeb 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET HAD SEDIMENT IN THE FILTER. THE SEDIMENT/UNIDENTIFIED OBJECT APPEARED TO BE SEDIMENT IN LINE OF THE DEVICE. THIS WAS NOTICED PRIOR TO PATIENT INVOLVEMENT WHILE THE TECHNICIAN WAS MIXING THE DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356997 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END (MALE LUER) OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET SLIPPED OUT. THIS WAS OBSERVED WHEN THE NURSE WAS RUNNING DEXTROSE 5% FLUIDS. 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 21125150 ↗
• MalfunctionJul 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET HAD BROWN AND FLAKY PARTICLES INSIDE THE FLUID PATH. THIS WAS OBSERVED AFTER THE INFUSION WAS COMPLETED. 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 19657590 ↗
• MalfunctionJun 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED UNSPECIFIED PARTICULATE WAS OBSERVED ¿INSIDE THE FILTER COMPARTMENT¿ OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET. THE PARTICLE WAS FURTHER DESCRIBED TO BE CARDBOARD OR ¿SIMILAR MATERIAL¿. THIS WAS OBSERVED PRIOR TO INTRAVENOUS PRODUCT PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564217 ↗
• MalfunctionApr 22, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET FILTER WAS FILLED WITH AIR. WHEN GOING TO HANG TOTAL PARENTERAL NUTRITION (TPN), THE CUSTOMER NOTICED THE FILTER WAS FILLED WITH AIR AND NO LONGER HAD TPN IN IT. THE TPN WAS TURNED ON (NOT ATTACHED TO PATIENT) TO ATTEMPT TO PRIME FILTER AND THE FILTER WOULD NOT PRIME. 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 19152797 ↗
• MalfunctionMar 6, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP EXTENSION SETS REMAINED FULL OF AIR; THE SETS DRAINED DRY ONCE THE CLAMP WAS OPENED AND DID NOT ALLOW FOR RE-PRIME. THIS OCCURRED AFTER PRIMING; THE SETS WERE CONNECTED TO A PATIENT. THE SETS WERE BEING USED FOR NORMAL SALINE AS A KEEP VEIN OPEN (KVO) LINE AND INTERMITTENT MEDICATIONS WERE GIVEN THROUGH THE LINE CONNECTED TO A SYRINGE 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 18848036 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET LEAKED. THIS OCCURRED WHEN THE SET WAS PRIMED WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736666 ↗

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
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8