CLEARLINK 2N8378Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00085412048918), received between Feb 20, 2018 and Oct 16, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

8 other recalls cover devices cleared under the same FDA submission (K112893); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CATHETER EXTENSION SET HAD A CUT/HOLE IN THE TUBING. THIS WAS OBSERVED WHEN THE PATIENT WAS GETTING IV (INTRAVENOUS) CONTRAST PUSHED THROUGH THE LINE. A CONTRAST INJECTOR AND IV CATHETER WERE 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 23314062 ↗
• MalfunctionMay 11, 2023Disconnection; Material Deformation; Disconnection; Material Deformation

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS WERE DAMAGED. THE SETS ARE RIGID AND DID NOT ALLOW FLEXIBILITY IN FIXATION AND CAUSES DISCOMFORT IN THE INSERTION OF THE CATHETER. ON SOME OCCASIONS THE SEAL IS DISCONNECTED, BECOMING DETACHED FROM THE CATHETER UNION. 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 16915506 ↗
• MalfunctionMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF TWO (2) CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS HAD BLOWN OUT AND BURST. 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 16531475 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET BROKE. IT WAS FURTHER REPORTED, "A PIECE BROKE OFF OF THE HUB" WHILE CONNECTED TO A 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 15325119 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT A SMALL PIECE BROKE OFF FROM THE SMALLER HUB OF A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET. THIS WAS OBSERVED WHEN GETTING READY FOR A SURGERY AND THE VEIN WAS BEING ACCESSED. 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 15316221 ↗
• MalfunctionSep 23, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET DETACHED BETWEEN THE LUER LOCK ADAPTER AND LINE. 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 12519507 ↗
• MalfunctionAug 2, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET AND A NON-BAXTER SYRINGE. IT WAS FURTHER STATED THE SET WAS STERILE WELDED TO A PRODUCT TRANSFER BAG IN ORDER TO CONNECT THE NON-BAXTER SYRINGE AND PERFORM SAMPLING USING THE LUER ACTIVATED VALVE. AFTER CONNECTING THE NON-BAXTER SYRINGE TO THE LUER ACTIVATED VALVE AND DURING SAMPLING, THE CONNECTION BETWEEN THE LUER ACTIVATED VALVE (MALE LUER LOCK) AND THE TUBING (FEMALE LUER LOCK) SUDDENLY DISCONNECTED WHICH RESULTED IN A LEAK. THE ISSUE WAS IDENTIFIED DURING SET UP AND PREPARATION. IT WAS STATED THAT INSTRUCTION OF USE WERE PROPERLY FOLLOWED IN TERMS OF PROPER ASEPTIC TECHNIQUE AND CAUTIONS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259359 ↗
• MalfunctionMay 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A BLOOD LEAK WITH A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. 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 11880668 ↗
• MalfunctionMay 25, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS UNDER INFUSED. IT WAS FURTHER REPORTED THAT THE UNSPECIFIED FLUID RUNS EXTREMELY SLOW. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. 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 11880664 ↗
• MalfunctionMay 25, 2021No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT ONCE THE DEVICE WAS CONNECTED TO THE PATIENT THE UNSPECIFIED FLUIDS WOULD NOT RUN AT ALL AND THE LINE COULD NOT BE FLUSHED. THIS WAS OBSERVED DURING PATIENT USE. THE EXTENSION SET WAS REPLACED AND THE ISSUE WAS RESOLVED. 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 11880536 ↗
• MalfunctionJan 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS LEAKED. IT WAS FURTHER REPORTED THE LEAK WAS OBSERVED ABOVE THE CONNECTION SITE ONCE IT WAS CONNECTED TO THE CATHETER HUB. THIS WAS FURTHER DESCRIBED AS THE LEAK OCCURRED UPON ATTACHING THE J-LOOP TO THE HUB OF IV (INTRAVENOUS) CATHETER. 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 11157837 ↗
• MalfunctionJan 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SIX (6) CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS LEAKED. IT WAS FURTHER REPORTED THE LEAKS WERE OBSERVED ABOVE THE CONNECTION SITE ONCE IT WAS CONNECTED TO THE CATHETER HUB. THIS RESULTED IN APPROXIMATELY 50ML OF BLOOD LOSS. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 11135350 ↗
• MalfunctionNov 23, 2020Backflow; Difficult to Flush; Backflow; Difficult to Flush

  IT WAS REPORTED THAT A CUSTOMER EXPERIENCED BACKFLOW OF BLOOD AFTER CONNECTING TO A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET ,AND THEN THE CUSTOMER COULD NOT SUCCESSFULLY CLEAR THE DEVICE OF BLOOD WHEN FLUSHING. AFTER PRIMING THE SET, FLUIDS SUCCESSFULLY WOULD RUN ALL THE WAY THROUGH THE TUBING; HOWEVER, WHEN THE SET WAS CONNECTED TO THE PATIENT, BLOOD BACK FLOWED INTO THE TUBING. TO CORRECT THIS ISSUE, THE CUSTOMER FLUSHED THE LINES; HOWEVER, WAS UNSUCCESSFUL IN CLEARING THE DEVICE OF THE BACK FLOWED BLOOD. THIS WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10886578 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LUER LOCK ADAPTER OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS WERE LEAKING. 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 Consequences Or Impact To Patient

  MAUDE report 10877053 ↗
• MalfunctionMay 18, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET WAS DEFECTIVE WHICH RESULTED IN A BLOOD LEAK. THE DEFECT WAS DESCRIBED AS A SLICE. THE DEFECT WAS ALSO DESCRIBED AS A DISTORTED LUMEN THAT WAS "MUCH MORE FLAT/NARROW THAN A TYPICAL EXTENSION SET SHOULD BE". IT WAS FURTHER REPORTED THAT THE TUBING APPEARED TO BE NARROW AT 2 CM AROUND THE DEFECT. THE LEAK WAS OBSERVED WHILE THE PATIENT WAS CONNECTED FOR THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067101 ↗
• MalfunctionApr 8, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET THAT WAS ATTACHED TO A PATIENT'S IV MALFUNCTIONED; FURTHER DESCRIBED AS DURING COMPUTED TOMOGRAPHY ANGIOGRAPHY THE J LOOP SPLIT AND RESULTED IN A LEAK OF CONTRAST. PRIOR TO THE PROCEDURE, LABS WERE TAKEN AND A J LOOP WAS ATTACHED AND THE SET FLUSHED WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938722 ↗
• MalfunctionDec 19, 2018Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF THREE (3) CLEARLINK SETS SPLIT WHILE IN USE ON PATIENTS FOR CT (COMPUTERIZED TOMOGRAPHY) DYE ADMINISTRATIONS. THE DYES WERE BEING INJECTED AT PSI 4 (POUNDS PER SQUARE INCH). THERE WAS NO REPORT OF PATIENT INJURIES OR MEDICAL INTERVENTIONS ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180129 ↗
• MalfunctionDec 7, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS HAD CRACK IN THE TUBING WHERE THE LARGER MORE RIGID TUBING DOWNSIZES TO THE STANDARD DIAMETER TUBING JUNCTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142404 ↗
• MalfunctionOct 1, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CLAMP OF THE CLEAR LINK CATHETER EXTENSION SET SLICED INTO THE PLASTIC TUBING RESULTING IN A HOLE. THIS OCCURRED WHEN THE PATIENT WAS SENT TO CT AND THE PATIENT'S IV WAS CLAMPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7924153 ↗
• MalfunctionSep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET SEPARATED. DURING PATIENT USE, THE CLEARLINK SET WAS ¿COMING APART¿ AFTER THE IV WAS CONNECTED. IT WAS FURTHER REPORTED, IF THE NURSE ¿DOES NOT CHECK OR RETIGHTEN UPON OPENING PACKAGE THESE HAVE COME LOOSE, WHILE BEING USED ON A PATIENT¿. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900135 ↗
• MalfunctionAug 13, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CATHETER EXTENSION SET SPLIT DURING INJECTION OF COMPUTED TOMOGRAPHY (CT) DYE USING A POWER INJECTOR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777822 ↗
• MalfunctionFeb 20, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING EVALUATION OF A RETURNED CLEARLINK CATHETER EXTENSION SET, THE SET WAS FOUND TO LEAK FROM BETWEEN THE LUER ACTIVATED VALVE AND THE WINGED FEMALE LUER LOCK ADAPTER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7283388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112893. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
• Z-0190-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
• Z-0199-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
• Z-0198-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
• Z-0197-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
• Z-1653-2022 · Aug 9, 2022 · Terminated
  Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
• Z-0099-2014 · Sep 4, 2013 · Terminated
  Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
• Z-1271-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte