CLEARLINK 2H8603Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00085412046433), received between Dec 28, 2017 and Feb 25, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

1 FDA recall record name this device's identifier, 1 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, 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-0200-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Crack; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET EXPLODED AND RESULTED IN LEAKAGE. THE ISSUE WAS DESCRIBED AS "THE FILTER WAS JAMMED AND WOULD NOT ALLOW MEDICATION THROUGH THE FILTER. A SALINE FLUSH WAS THEN USED TO TRY TO FLUSH THROUGH THE FILTER AND THE FILTER EXPLODED." THIS OCCURRED DURING PRIMING FOR AN INFLIXIMAB INFUSION; HOWEVER, IT WAS UNSPECIFIED WHETHER THE PATIENT WAS CONNECTED. 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 24444830 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT THE "CLEAR PART OF THE FILTER" OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET BROKE OFF. THE ISSUE OCCURRED WHILE PRIMING THE SET WITH TOTAL PARENTERAL NUTRITION (TPN). THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532815 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK NON-DEHP EXTENSION SET FELL APART. WHILE ATTEMPTING TO PRIME, PRIOR TO ADMINISTRATION, IT WAS OBSERVED THAT THE CLEAR OUTER HOUSING FELL OFF THE FILTER. TO RESOLVE THIS ISSUE THE FILTER WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786093 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED AT THE FILTER. THIS WAS OBSERVED DURING PATIENT INFUSION. THE DEVICE CONTAINED TPN (TOTAL PARENTERAL NUTRITION). 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 22648626 ↗
• MalfunctionJun 18, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET DID NOT FLOW TOTAL PARENTERAL NUTRITION THROUGH THE FILTER. THE DEVICE WAS REMOVED AND FLUSHED WITH NORMAL SALINE, BUT THE NURSE WAS UNABLE TO FLUSH. THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286487 ↗
• MalfunctionMay 29, 2025Disconnection; Fluid/Blood Leak; Air/Gas in Device; Disconnection; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SETS DISCONNECTED FROM AT LEAST ONE (1) PATIENT. THE EVENT WAS FURTHER DESCRIBED AS "THE FILTER HAS EVACUATED SPONTANEOUSLY". THIS OCCURRED WHILE THE SETS WERE BEING USED WITH A NON-BAXTER PRIMARY PUMP SET AND A NON-BAXTER INFUSION PUMP. THIS EVENT RESULTED IN FLUID/MEDICATIONS SPILLING ONTO THE FLOOR AND AIR IN THE INTRAVENOUS (IV) TUBING. THIS OCCURRED DURING PATIENT INFUSION WITH PROPOFOL AND/OR HYDROMORPHONE. THE MEDICATIONS WERE DISCONNECTED FROM THE PATIENT AFTER THE INFUSION WAS PAUSED. 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 22109793 ↗
• MalfunctionSep 9, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET BACK FILLED THE LINE WITH AIR. THE EVENT OCCURRED WHEN THE DEVICE WAS CONNECTED TO THE PATIENT AND THE PUMP WAS STARTED. THE AIR FILTER WAS SUCCESSFULLY PRIMED WITH TPN (TOTAL PARENTERAL NUTRITION). AFTER THE AIR IN THE TUBING LINE WAS OBSERVED THE INFUSION WAS STOPPED AND THE TUBING WAS CHANGED. 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 20171047 ↗
• MalfunctionJul 23, 2024Filling Problem; Air/Gas in Device; Filling Problem; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS UNDERINFUSED DURING PATIENT INFUSION. AIR WAS GATHERING IN THE FILTER DURING PRIMING. ONCE ALL THE AIR WAS ELIMINATED, THE PATIENTS WERE NOT GETTING THE FULL 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 19812399 ↗
• MalfunctionMay 10, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THE FILTERS IN THREE (3) CLEARLINK SYSTEM NON-DEHP EXTENSION SETS APPEARED TO BE CRACKED WHICH SUBSEQUENTLY LEAKED. THE EVENTS OCCURRED DURING UNKNOWN PROCESS STEPS. 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 19291082 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WAS LEAKING TOTAL PARENTERAL NUTRITION FROM THE FILTER. THE LEAK 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 18220101 ↗
• MalfunctionMar 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET WAS LEAKING TOTAL PARENTERAL NUTRITION (TPN) FROM THE SIDE PORT. THIS WAS OBSERVED DURING PATIENT INFUSION USING AN UNSPECIFIED PUMP. WHEN THE LEAK WAS FOUND, A GREEN CAP (NON-BAXTER) WAS PLACED ON THE SIDE PORT; WHEN THE CAP WAS REMOVED, TPN SPRAYED OUT OF THE SIDE PORT. TO RESOLVE THE EVENT, THE TPN HAD TO BE RE-SPIKED WITH NEW TUBING. 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 16590332 ↗
• MalfunctionMar 17, 2023Backflow; Backflow

  IT WAS REPORTED THAT THERE WAS BACKFLOW OF BLOOD INTO THE FILTER FROM THE NON-BAXTER CATHETER WHEN USING A CLEARLINK SYSTEM NON-DEHP EXTENSION SET; NOTHING WAS CLAMPED AND THE UNSPECIFIED PUMP WAS PROGRAMMED AND RUNNING. THIS WAS IDENTIFIED DURING PATIENT INFUSION OF LIPIDS. THE SET WAS REPLACED. 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 16565334 ↗
• MalfunctionMar 16, 2023No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH THE FILTER OF TWO (2) CLEARLINK SYSTEM NON-DEHP EXTENSION SETS. WHILE PRIMING THE SETS, THERE WAS NO FLUID FLOW THROUGH THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554498 ↗
• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET HAD FILTER "BUSTED". THIS EVENT OCCURRED DURING AN UNSPECIFIED 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 16035008 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET HAD FILTER "BUSTED DURING INFUSION". THIS EVENT OCCURRED DURING AN UNSPECIFIED 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 16009552 ↗
• MalfunctionJun 20, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET. THIS ISSUE WAS IDENTIFIED DURING THE START OF AN 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 14745060 ↗
• MalfunctionJun 20, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET SEPARATED FROM THE FILTER. THIS WAS OBSERVED DURING A 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 14743966 ↗
• MalfunctionMay 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SETS WERE LEAKING FROM THE SIDE OF THE PORT. THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14462663 ↗
• MalfunctionDec 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS "TPN (TOTAL PARENTERAL NUTRITION) FLUID WAS SEEPING OUT OF ONE OF THE INDENTS (HOLES) IN THE BACK OF THE TPN FILTER CARTRIDGE". IT WAS STATED THE PATIENT AND THEIR BED LINENS WERE DAMP. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002533 ↗
• MalfunctionOct 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS A LEAK AROUND THE ¿FILTER AREA¿ ON THE SET. THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616186 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP EXTENSION SET LEAKED DURING PATIENT INFUSION WITH REMICADE. IT WAS FURTHER REPORTED APPROXIMATELY 20-30 ML LEAKED ONTO THE PATIENT'S LINENS AND CHAIR. THE SET WAS REPLACED AND 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 12583117 ↗
• MalfunctionSep 20, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THERE WAS NO FLOW OF MEDICATION THROUGH A CLEARLINK SYSTEM NON-DEHP EXTENSION SET. IT WAS FURTHER REPORTED THAT THE FILTER BECAME CLOGGED DURING LIPID ADMINISTRATION WHICH CAUSES A DELAY OF THE ADMINISTRATION. TO RESOLVE THIS ISSUE, THE SET WAS REPLACED, AND THERAPY WAS CONTINUED. 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 12502325 ↗
• MalfunctionSep 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET LEAKED CLOSE TO ONE OF THE SEALED AREAS. THE ISSUE WAS IDENTIFIED DURING PRIMING WHILE USING A 20% UNSPECIFIED INTRALIPID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416157 ↗
• MalfunctionSep 18, 2020No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP EXTENSION SET WOULD NOT FLOW. THE EVENT WAS FURTHER DESCRIBED AS THE MEDICATION WOULD NOT FLOW PAST THE FILTER CHAMBER. THIS ISSUES WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10552813 ↗
• MalfunctionFeb 6, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP EXTENSION SETS WOULD NOT PRIME. THE EVENT WAS FURTHER DESCRIBED AS ¿THE MEDICATION FILLS THE FILTER PARTIALLY AND BECOMES BLOCKED; THE MEDICATION WILL NOT COMPLETELY FILL FILTER OR FLOW PAST FILTER¿. THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9679296 ↗