CLEARLINK 2H8486Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00085412074764), received between Feb 4, 2019 and Sep 11, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Failure to Prime” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K952074); 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736287 ↗
• MalfunctionApr 24, 2026Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET LEAKED MEDICATION FROM THE LUER LOCK IV PORT ABOVE THE FILTER. THIS OCCURRED DURING INFUSION OF INFLIXIMAB. THE INFUSION WAS STARTED AT A RATE OF 40ML/HR. AFTER 30 MINUTES, THE INFUSION RATE WAS SET TO 80ML/HR. 25 MINUTES LATER, THE HEALTHCARE PROFESSIONAL CHECKED ON THE PATIENT AND IDENTIFIED THAT THE MEDICATION HAD LEAKED ON THE FLOOR. IV AND IV LINES ALL APPEAR TO BE INTACT. THE MEDICATION BAG WAS EMPTY AND MEDICATION LINE APPEARS TO HAVE BACKFLOW OF BLOOD. THE HEALTHCARE PROFESSIONAL INSPECTED THE LINES FURTHER AND NOTED ONE OF THE LUER LOCK IV PORTS ABOVE THE FILTER TO BE LEAKING FLUIDS. THE LINE WAS FLUSHED WITH SALINE. PATIENT RECEIVED APPROXIMATELY 1/4-1/3 OF 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 24988216 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM A 1 INCH HOLE IN THE TUBING. THIS WAS OBSERVED WHEN THE NURSE TRIED TO PRIME THE TUBING WITH TPN (TOTAL PARENTERAL NUTRITION). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087084 ↗
• MalfunctionJan 13, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN OVERINFUSION OF MEDICATION OCCURRED WHILE USING AN UNSPECIFIED QUANTITY OF CLEARLINK, NON-DEHP SOLUTION SETS. THE INFUSIONS ARE SET FOR 24 HOURS AND APPROXIMATELY 2L, BUT THE PUMPS ARE RUNNING OUT OF FLUID ABOUT 30 MINUTES EARLY AND DELIVERING 50-60 ML MORE THAN PRESCRIBED. THESE OVERINFUSIONS OCCURRED WITH SIGMA SPECTURM PUMPS DURING TPN (TOTAL PARENTERAL NUTRITION) TREATMENTS. 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 21138693 ↗
• MalfunctionOct 2, 2024No Flow; No Flow

  IT WAS REPORTED THAT SOLUTION WOULD NOT FLOW THROUGH THE FILTER OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿TPN TUBING WOULD NOT FLUSH THROUGH FILTER ¿ TPN FLUSHED BACK INTO BAG ¿ NORMAL SALINE USED TO CLEAR TUBING AND ALSO WOULD NOT FLUSH PAST FILTER¿. 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 20354805 ↗
• MalfunctionJul 8, 2024Fluid/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 NON-DEHP SOLUTION SET SEPARATED FROM THE LUER LOCK WHICH RESULTED IN A FLUID LEAK. THIS EVENT WAS FURTHER DESCRIBED AS, ¿THE TUBING USED TO INFUSE TPN HAD DISCONNECTED FROM THE CAP AND THE CAP REMAINED ATTACHED TO THE PICC LUMEN¿. 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 19693309 ↗
• MalfunctionMay 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS LEAKING AT THE FILTER SITE. THE LEAK WAS OBSERVED WHILE RUNNING LIPIDS 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 19260128 ↗
• MalfunctionDec 27, 2022No Flow; Air/Gas in Device; No Flow; Air/Gas in Device

  IT WAS REPORTED THAT WHEN THE AIR AT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET IS EMPTIED, IT NO LONGER FLOWS AT ALL. THE ISSUE WAS IDENTIFIED 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 16051981 ↗
• MalfunctionDec 2, 2022No Flow; Air/Gas in Device; No Flow; Air/Gas in Device

  IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN A CLEARLINK SYSTEM NON-DEHP SOLUTION SET. IT WAS FURTHER REPORTED THAT THE CLAMP WAS NOT ALLOWING SOLUTION TO FLOW. THE ISSUE WAS IDENTIFIED 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 15905564 ↗
• MalfunctionDec 2, 2022No Flow; Air/Gas in Device; No Flow; Air/Gas in Device

  IT WAS REPORTED THAT AIR BUBBLES WERE LEAKING INTO A CLEARLINK SYSTEM NON-DEHP SOLUTION SET. ADDITIONALLY, IT WAS REPORTED THAT CLAMP WAS NOT ALLOWING SOLUTION TO FLOW. THIS ISSUE WAS IDENTIFIED 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 15904469 ↗
• MalfunctionDec 1, 2022No Flow; Air/Gas in Device; No Flow; Air/Gas in Device

  IT WAS REPORTED THAT AN AIR BUBBLES WERE OBSERVED IN A CLEARLINK SYSTEM NON-DEHP SOLUTION SET. IT WAS FURTHER REPORTED THAT THE CLAMP WAS NOT ALLOWING SOLUTION TO FLOW. THE ISSUE WAS IDENTIFIED 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 15895767 ↗
• MalfunctionSep 13, 2021Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET FILLED WITH AIR. IT WAS STATED THAT THE SET WAS PRIMED FOR USE WITH ENTERAL NUTRITION. WHEN THE NURSE INVERTED THE FILTER TO ATTACH THE LINE TO THE PATIENT'S CENTRAL LINE, THE LINE BEGAN TO FILL WITH AIR FROM THE MALE LUER ADAPTER BACK TOWARD THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461480 ↗
• MalfunctionSep 10, 2021Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET HAD AIR IN LINE. IT WAS STATED THAT THE SET WAS PRIMED FOR USE WITH ENTERAL NUTRITION. WHEN THE NURSE INVERTED THE FILTER TO ATTACH THE LINE TO THE PATIENT'S CENTRAL LINE, THE LINE BEGAN TO FILL WITH AIR FROM THE MALE LUER ADAPTER BACK TOWARD THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452670 ↗
• MalfunctionAug 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS LEAKING. THIS WAS OBSERVED DURING PRIMING WITH LIPIDS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344470 ↗
• MalfunctionAug 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED. IT WAS FURTHER REPORTED THAT UPON STARTING A LIPID ADMINISTRATION, LIPIDS WERE COMING OUT OF THE PORT LOCATED RIGHT ABOVE THE FILTER. THE ISSUE WAS IDENTIFIED DURING USE. AS A RESULT, A NEW LIPID SOLUTION WAS MADE BY THE PHARMACY, AND A NEW SETUP WAS USED TO DELIVER THE PATIENT INFUSION. 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 12291530 ↗
• MalfunctionJun 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED. THE LEAK WAS FURTHER DESCRIBED AS "THE BAG WAS SPIKED AND THE TUBING WAS PRIMED, LIPID SOLUTION WAS NOTED TO BE LEAKING FROM THE PORT LOCATED ABOVE THE FILTER." THIS OCCURRED DURING PRIMING OF THE DEVICE, PRIOR TO 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 12078766 ↗
• MalfunctionDec 2, 2020Crack; Crack

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET BROKE. IT WAS FURTHER REPORTED THE LINE BROKE OFF WHEN THE USER UNCLAMPED THE LINE AFTER THE FILTER ON THE END OF THE LINE. THE PLASTIC APPEARED CRACKED. THIS ISSUE WAS IDENTIFIED DURING PRIMING; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE..

  Patient problems: No Patient Involvement

  MAUDE report 10931812 ↗
• MalfunctionOct 8, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A LARGE AIR BUBBLE WAS OBSERVED COMING FROM THE DISTAL END FILTER OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS. THE SET WAS USED WITH LIPID THAT WAS CONNECTED TO AN UNSPECIFIED BAXTER PUMP. THIS 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 Consequences Or Impact To Patient

  MAUDE report 10651267 ↗
• MalfunctionMay 1, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WOULD NOT PRIME PAST THE FILTER. THE CUSTOMER WAS PRIMING LIPIDS THROUGH THE SET PRIOR TO PATIENT USE; HOWEVER, THE TUBING WOULD NOT PRIME ONCE THE LIPIDS REACHED THE FILTER. MULTIPLE UNSUCCESSFUL ATTEMPTS TO PUSH LIPIDS THROUGH THE SET WERE ATTEMPTED. TO RESOLVE THE ISSUE, THE SET WAS REPLACED, AND TREATMENT WAS ABLE TO CONTINUE WITH THE NEW SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10018888 ↗
• MalfunctionApr 6, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK NON-DEHP SOLUTION SETS WOULD NOT FLOW DURING PRIMING. THE REPORTER STATED THAT THE LIPIDS STOPPED FLOWING ONCE THEY REACHED THE FILTER. THE LIPIDS BEING USED WERE 50 GRAMS IN 250 MLS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9930922 ↗
• MalfunctionApr 6, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK NON-DEHP SOLUTION SETS WOULD NOT FLOW DURING PRIMING. THE REPORTER STATED THAT THE LIPIDS STOPPED FLOWING ONCE THEY REACHED THE FILTER. THE LIPIDS BEING USED WERE 50 GRAMS IN 250 MLS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9930921 ↗
• MalfunctionMar 25, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT TWO CLEARLINK NON-DEHP SOLUTION SETS WERE UNABLE TO BE PRIMED. THE EVENT OCCURRED DURING PRIMING WITH UNSPECIFIED LIPIDS, DESCRIBED AS "50 GRAMS IN 250 MLS". THE REPORTER STATED THAT THE CHECK VALVE WAS INVERTED AND TAPPED, THE BAG WAS NOT INITIALLY SQUEEZED BUT AFTER THE LIPID STOPPED FLOWING AT THE FILTER THE BAG WAS THEN SQUEEZED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9878779 ↗
• MalfunctionMar 20, 2020No Flow; No Flow

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WOULD NOT FLOW. THE DEVICE WAS FILLED WITH 50G OF LIPIDS IN 250ML. IT WAS FURTHER REPORTED THE ¿LIPIDS WOULD NOT FLOW THROUGH THE FILTER.¿ ¿THE CHECK VALVE WAS INVERTED AND TAPPED, THE BAG WAS NOT INITIALLY SQUEEZED BUT AFTER THE LIPID WOULD STOP FLOWING AT THE FILTER THE BAG WOULD THEN BE SQUEEZED.¿ THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862453 ↗
• MalfunctionMar 9, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT SEVEN (7) CLEARLINK SYSTEM NON-DEHP SOLUTION SETS FAILED TO PRIME. DURING PRIMING, IT WAS DISCOVERED THAT THE CUSTOMER COULD NOT PUSH LIPIDS THROUGH THE SETS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9807476 ↗
• MalfunctionMar 5, 2020Failure to Prime; Failure to Prime

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WOULD NOT PRIME. IT WAS FURTHER REPORTED THE USER "COULD NOT GET THE LIPID FLUID TO PRIME PAST THE FILTER". THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9793468 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952074. One submission often covers many models, so check the product and lot details in each record.

• Z-0200-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H86