CLEARLINK 2C8612Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00085412070056), received between Jan 21, 2019 and Sep 15, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  It was reported that a CLEARLINK System Extension Set contained black particulate matter inside the intravenous fluid path (in the tubing). The issue was noticed during setup after the set had been hung and primed. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766705 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM EXTENSION SETS LEAKED FROM THE FIRST LUER LOCK CONNECTOR DOWNLINE ON THE TUBING. THE LEAK WAS FROM A BOND SEPARATION FROM THE TUBING AND LUER. THIS WAS OBSERVED DURING GRAVITY FEED OF IV (INTRAVENOUS) SOLUTION. 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 22341287 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS CAME APART "AT THE CONNECTION". THIS WAS OBSERVED WHILE IN USE ON PATIENTS. 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 21968199 ↗
• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS WERE LEAKING FROM THE INJECTION SITES. THE LEAKING WAS DISCOVERED 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 20477275 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS LEAKED AT THE PORTS. THIS 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 20466302 ↗
• MalfunctionApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM AN UNSPECIFIED PORT. THIS WAS OBSERVED DURING PATIENT INFUSION; A PUMP WAS NOT USED FOR TREATMENT. THE EXTENSION SET WAS CONNECTED TO A PRIMARY 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 19213329 ↗
• MalfunctionApr 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM ONE OF THE UNSPECIFIED PORTS. THIS WAS OBSERVED 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 16733869 ↗
• MalfunctionNov 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY AT LEAST FOUR (4) OF CLEARLINK SYSTEM EXTENSION SETS HAD FEMALE CONNECTORS ON BOTH ENDS. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886501 ↗
• MalfunctionNov 29, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE END OF THE TUBING (LUER) OF A CLEARLINK SYSTEM EXTENSION SET WAS DIFFERENT. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877425 ↗
• MalfunctionNov 28, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TUBING ENDS (LUER) OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS WERE DIFFERENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15871961 ↗
• MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM THE BOTTOM PORT WHILE ATTACHED TO THE UNSPECIFIED PUMP TUBING. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14856856 ↗
• MalfunctionJan 6, 2022Failure to Disconnect; Connection Problem; Failure to Disconnect; Connection Problem

  IT WAS REPORTED THAT THE NURSE PRESSED THE RETRACT BUTTON ON A CLEARLINK SYSTEM EXTENSION SET AND IT DID NOT RETRACT. THE ISSUE WAS IDENTIFIED DURING PERIPHERAL INTRAVENOUS (PIV) PLACEMENT. THE PIV WENT SIDEWAYS UPON HITTING THE RETRACT BUTTON AND BECAME STUCK IN THE CATHETER. IT TOOK THREE HANDS TO REMOVE THE NEEDLE FROM THE CATHETER. 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 13177582 ↗
• MalfunctionDec 16, 2021Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM EXTENSION SETS WERE ¿BREAKING AND BLOWING OUT¿. THIS WAS IDENTIFIED DURING 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 13022441 ↗
• MalfunctionDec 16, 2021Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS WERE ¿BREAKING AND BLOWING OUT¿. THIS WAS IDENTIFIED DURING 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 13022101 ↗
• MalfunctionDec 15, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WAS SEPARATING APART; FURTHER DESCRIBED AS "BREAKING AND BLOWING OUT". THIS ISSUE WAS IDENTIFIED 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 13013664 ↗
• MalfunctionMar 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ACCESS PORTS OF FOUR (4) CLEARLINK SYSTEM EXTENSION SETS WERE LEAKING. THESE EVENTS OCCURRED DURING UNSPECIFIED PROCESS STEPS FOR ¿PROPOFOL DRIPS¿. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456638 ↗
• InjuryMar 8, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT INFUSION OF PHENYLEPHRINE WITH A CLEARLINK EXTENSION SET, A LEAK OCCURRED DUE TO ¿BROKEN APART¿ TUBING. THE LOCATION OF THE SEPARATION WAS SPECIFIED AS ¿WHERE THE Y SITES MEET THE TUBING, THE SEAM BROKE APART¿. THE CAUSE WAS NOT REPORTED. IT WAS REPORTED ONE END OF THE TUBING THAT WAS STILL CONNECTED TO THE PATIENT¿S LINE WAS ¿BACK FLOWING FILLING¿ WITH BLOOD WHICH RESULTED IN AN ESTIMATED BLOOD LOSS OF LESS THAN 100ML. THE HEMOGLOBIN LEVEL BEFORE AND AFTER THE EVENT WAS REPORTED AS STABLE AND NO BLOOD TRANSFUSION WAS REQUIRED. IT WAS REPORTED THE ¿BROKEN APART¿ TUBING DELAYED THE DELIVERY OF THE MEDICATION INFUSION, WHICH RESULTED IN A BLOOD PRESSURE DROP TO ¿80S/40S¿. PRIOR TO THE DELAY, THE BLOOD PRESSURE READING WAS ¿110¿S/70¿S¿. IT WAS REPORTED THE PATIENT WAS STABLE AND DID NOT REQUIRE INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 11436946 ↗
• MalfunctionAug 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET HAD A "PARTICULATE ISSUE" (NOT SPECIFIED). THIS ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10376198 ↗
• MalfunctionDec 16, 2019Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED A CLEARLINK SYSTEM EXTENSION SET LEAKED. DURING AN UNSPECIFIED SURGICAL PROCEDURE, "THE TUBING SPLIT WHEN THE FLOW WAS INCREASED AND CONTENTS SPILLED." THE TUBING WAS REPLACED. 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 9477570 ↗
• MalfunctionJun 17, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT ¿PULLED APART¿ A CLEARLINK EXTENSION SET 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 8705539 ↗
• MalfunctionJun 12, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A ¿BAD CONNECTOR¿ (NO FURTHER DETAIL) WAS OBSERVED ON A CLEARLINK EXTENSION SET WHICH RESULTED IN A DISCONNECTION AND A BLOOD LEAK WHILE IN USE ON A PATIENT. THIS WAS FURTHER DESCRIBED AS A ¿PROXIMAL 1¿ MALE LUER ¿CONNECTION POPS OPEN AND BLOOD SPILLS¿. THIS WAS IDENTIFIED DURING ¿THE MIDDLE¿ OF AN UNSPECIFIED PATIENT INFUSION. THE PATIENT NOTICED THE DISCONNECTION AND ALERTED THE MEDICAL STAFF. THE AMOUNT OF BLOOD LOSS WAS REPORTED TO BE ¿MINIMAL¿. 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 8692442 ↗
• MalfunctionMay 21, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CAP OF A CLEARLINK LUER ACTIVATED VALVE DISCONNECTED FROM THE TUBING 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 8629683 ↗
• MalfunctionMay 21, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CAP OF A CLEARLINK LUER ACTIVATED VALVE DISCONNECTED FROM THE TUBING 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 8629680 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK EXTENSION SETS LEAKED WHILE IN USE ON PATIENTS. THE LEAKS WERE OBSERVED AT THE HUB WHERE THE PATIENT¿S ANGIOCATHETER AND THE EXTENSION SET WERE CONNECTED. THE EVENTS WERE OBSERVED EITHER PRE-OPERATIVELY AFTER THE IV WAS INSERTED AND PRIOR TO THE PATIENT RECEIVING A REGIONAL BLOCK, OPERATIVELY, OR POST-OPERATIVELY. BOTH 20 AND 22 GAUGE ANGIOCATHETERS WERE USED. 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 8552755 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK EXTENSION SETS LEAKED WHILE IN USE ON PATIENTS. THE LEAKS WERE OBSERVED AT THE HUB WHERE THE PATIENT¿S ANGIOCATHETER AND THE EXTENSION SET WERE CONNECTED. THE EVENTS WERE OBSERVED EITHER PREOPERATIVELY AFTER THE IV WAS INSERTED AND PRIOR TO THE PATIENT RECEIVING A REGIONAL BLOCK, OPERATIVELY, OR POSTOPERATIVELY. BOTH 20 AND 22 GAUGE ANGIOCATHETERS WERE USED. 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 8552723 ↗

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-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-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-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-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-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-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