CLEARLINK 2R8486Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00085412565675), received between Nov 19, 2019 and Apr 17, 2026 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (27 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET LEAKED DURING A PARENTERAL NUTRITION INFUSION. CUSTOMER INDICATED THAT THE LEAK WAS DUE TO "A PIN HOLE AT OR NEAR THE DRIP CHAMBER". 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 24915256 ↗
• InjuryApr 1, 2026Backflow; Crack

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET HAD AN ACTIVE BLEEDING AT THE PATIENT¿S PICC TRIPLE Y SITE (PRECISE SOURCE IS UNCLEAR), AS WELL AS LIPID AND BLOOD BLACKFLOW. THE IV LINE REPORTEDLY CRACKED AT THE FILTER THE PREIVOUS NIGHT, RESULTING IN BLEEDING WHILE THE LINE WAS OPEN; THE KETAMINE PUMP WAS REPLACED AT THAT TIME, AND NO FURTHER ISSUES OCCURRED WHEN THE FILTER WAS NOT IN USE. LINE CAPS WERE CHANGED AT 04:00 DURING BLOOD CULTURE COLLECTION WITHOUT PRIOR CONCERNS. THE PATIENT WAS LATER FOUND "SOAKED IN BLOOD", PROMPTING DISPOSAL OF THE TPN AND INITIATION OF NEW INFUSIONS. THE PICC ITSELF APPEARED STRUCTURALLY INTACT, AND NO PUMP ALARMS OCCURRED; THE DURATION OF TIME THE PATIENT WAS WITHOUT ANALGESIA IS UNKNOWN. THE FOLLOWING DAY, THERAPY WAS INITIATED USING A SPECTRUM IQ INFUSION PUMP. A 1.2 MICRON FILTER WAS ADDED TO ONE LIMB OF THE TRIPLE Y DUE TO COMPATIBILITY CONCERNS BETWEEN KETAMINE AND AMINO ACIDS. IMMEDIATELY AFTER FILTER PLACEMENT, LIPIDS WERE OBSERVED BACKFLOWING INTO THE KETAMINE SYRINGE LINE, AND BLOOD WAS BACKFLOWING FROM THE RED LUMEN; HOWEVER, BOTH LINES FLUSHED EASILY AND REMAINED PATENT. THE SPECTRUMP PUMP WAS SUBSEQUENTLY CHANGED, AFTER WHICH FLOW NORMAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24757875 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET LEAKED LIPIDS FROM THE Y-SITE PORT. THIS OCCURRED DURING LIPID INJECTABLE EMULSION (SMOF) TREATMENT. THE LEAK WAS NOTICED APPROXIMATELY 4.5 HOURS AFTER THE START OF 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 24701188 ↗
• MalfunctionJan 3, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS OVER-INFUSED WHILE BEING USED WITH SPECTRUM INFUSION PUMPS. THE INFUSIONS COMPLETED APPROXIMATELY 1 TO 3 HOURS PRIOR TO THE INTENDED DURATION. THE EVENTS OCCURRED DURING TOTAL PARENTERAL NUTRITION (TPN) INFUSION VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). TO PREVENT HYPOGLYCEMIA, A DEXTROSE 5% (D5) INFUSION WAS PROMPTLY INITIATED. 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 23953054 ↗
• MalfunctionJan 3, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP SOLUTION SETS OVER-INFUSED WHILE BEING USED WITH SPECTRUM INFUSION PUMPS. THE INFUSIONS COMPLETED APPROXIMATELY 1 TO 3 HOURS PRIOR TO THE INTENDED DURATION. THE EVENTS OCCURRED DURING TOTAL PARENTERAL NUTRITION (TPN) INFUSION VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). TO PREVENT HYPOGLYCEMIA, A DEXTROSE 5% (D5) INFUSION WAS PROMPTLY INITIATED. 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 23953051 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FILTER OF 3-4 CLEARLINK NON-DEHP SOLUTION SETS CAME APART, AND A LEAK WAS OBSERVED. THESE ISSUES WERE OBSERVED DURING PATIENT INFUSION OF AN UNSPECIFIED CHEMOTHERAPY. 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 23348243 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM THE BLUE FILTER DURING PATIENT INFUSION WHEN THE LIPID LINE STARTED. 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 22889295 ↗
• MalfunctionJun 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK NON-DEHP SOLUTION SET WAS CUT WHICH RESULTED IN A PARENTERAL NUTRITION LEAK. THE CUT WAS DESCRIBED AS, ¿A PART OF THE TUBING MISSING CAUSING LEAK¿ AND ¿A SOFT PART OF THE TUBING ¿ ALMOST LIKE A SLICE WAS TAKEN OUT OF IT BY A SHARP OBJECT¿. THIS ISSUE WAS DISCOVERED BEFORE A PATIENT WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158743 ↗
• MalfunctionJun 5, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET LEAKED FROM THE MIDDLE OF THE TUBING. THE ISSUE WAS FURTHER DESCRIBED AS "MISSING PART OF THE TUBING" AND THERE WAS "A SLICE INTO THE TUBING". THIS WAS NOTICED WHILE SPIKING A TOTAL PARENTERAL NUTRITION (TPN) BAG DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153569 ↗
• MalfunctionFeb 19, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS CRACKED AND LEAKED. THIS 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 21411842 ↗
• MalfunctionNov 25, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLN SET LEAKED. THE BLUE FILTER TOWARDS THE END OF TUBING HAD A LEAK OR CRACK. THIS OCCURRED WHEN THE TUBING WAS PRIMED WITH THE IV INFUSION OF INFLIXIMAB. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771443 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP SOLN SETS LEAKED FROM THE DRIP CHAMBER DOWN THE LINE. THIS WAS WAS IDENTIFIED DURING PATIENT THERAPY WITH TOTAL PARENTERAL NUTRITION (TPN). 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 19386801 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET LEAKED BELOW THE DRIP CHAMBER WHEN PRIMING WITH SOLUTION. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042342 ↗
• MalfunctionJan 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET LEAKED FROM CHAMBER AND TUBING CONNECTION. 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 18479827 ↗
• MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED LIPID SOLUTION AT THE CONNECTION BETWEEN THE DRIP CHAMBER AND INTRAVENOUS LINE. THIS OCCURRED 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 18446024 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK NON-DEHP SOLUTION SET HAD A HOLE ABOUT 1.5 INCHES LONG IN THE MIDDLE OF THE TUBING. THIS WAS OBSERVED DURING PRIMING. THE TOTAL PARENTERAL NUTRITION (TPN) CONTAINING TUBE LEAKED THOUGH THE CLAMP AND CAP WAS ON THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331138 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLN SET LEAKED. DURING PATIENT INFUSION WITH LIPIDS, AN UNSPECIFIED INFUSION PUMPED ALARMED OCCLUSION, THE NURSE FLUSHED THE LINE WITH 1ML SYRINGE WITH NO ISSUES NOTED. THE INFUSION "WORKED FOR A LITTLE BIT", THEN ALARMED AGAIN. THE DRESSING WAS REMOVED AND CONDENSATION AROUND THE VALGUARD WAS OBSERVED. THE SET WAS FLUSHED AGAIN AND A LEAK WAS OBSERVED AT THE CLEARLINK AND FROM THE DEVICE 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 16694267 ↗
• MalfunctionApr 6, 2023Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLN SET WOULD NOT FLOW. DURING PRIMING OF LIPIDS, THE TUBING WAS KINKED INSIDE THE FILTER. THE LIPIDS WERE ABLE TO FLOW UP UNTIL THE FILTER; HOWEVER, WOULD NOT FLOW PAST THE FILTER. THE SET WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16694172 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT A CLEARLINK SOLUTION SET ¿CRACKED AT SPIKE WHERE TUBING BEGINS AND SPIKE ENDS.¿ THIS 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 16585179 ↗
• MalfunctionMar 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM THE TUBING JUST BELOW THE DRIP CHAMBER. THIS 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 16577145 ↗
• MalfunctionMar 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET LEAKED FROM THE "TOP NEAR THE PATIENT LINE". THIS WAS IDENTIFIED DURING A TRAINING SESSION ON A DUMMY TUMMY, AFTER PRIMING WAS COMPLETE. THE LEAK WAS OBSERVED WHEN THE CAP WAS STILL ON AND SOLUTION WAS DRIPPING UNDER THE CAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574906 ↗
• MalfunctionMar 16, 2023Backflow; Air/Gas in Device; Backflow; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET HAD AIR IN THE LINE; FURTHER DESCRIBED AS A LARGE AIR BUBBLE EXITED FROMTHE LIPID TUBING FILTER. AFTER REMOVING THE AIR BUBBLE AND CONNECTING BACK TO THE PATIENT, THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE BEGAN TO BACKFLOW BLOOD INTO THE LIPID TUBING AND UP INTO THE FILTER. THIS WAS IDENTIFIED 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 16553060 ↗
• MalfunctionDec 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED WHERE DRIP CHAMBER CONNECTS TO THE TUBING. THE ISSUE WAS IDENTIFIED 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 15915910 ↗
• MalfunctionNov 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS LEAKING CLOSE TO THE SPIKE SECTION. THE SET WAS USED FOR LIPID INFUSION ATTACHED TO AN UNSPECIFIED INFUSION PUMP. 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 15829182 ↗
• MalfunctionNov 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLN SET WAS LEAKING LIPIDS BELOW THE DRIP CHAMBER. THIS WAS OBSERVED DURING PATIENT INFUSION. THE INFUSION WAS STOPPED AND THE TUBING DISCONNECTED. NEW TUBING WAS PRIMED AND RECONNECTED. 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 15818223 ↗