CLEARLINK 2C8607Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412071671), received between May 15, 2019 and Jul 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K130245); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Defective Component; Physical Resistance/Sticking; Defective Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE END (LUER ADAPTER) OF A CLEARLINK SYSTEM EXTENSION SET APPEARED TO BE DEFORMED. THIS OCCURRED DURING SETUP FOR AN INTRAVENOUS (IV) INFUSION, WHERE AN UNSPECIFIED INTRAVENOUS FLUID (IVF) WAS CONNECTED TO AN UNSPECIFIED PRIMARY TUBING AND THE EXTENSION TUBING. WHEN ATTEMPTING TO CONNECT THE EXTENSION TUBING TO THE IV CATHETER, THE END OF THE EXTENSION TUBING APPEARED DEFORMED AND WOULD NOT ATTACH TO THE IV CATHETER. APPEARED TO GET STUCK AND COULD NOT TURN EVEN ON TUBING. THE SET WAS REPLACED TO RESOLVE THE ISSUE. 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 22613428 ↗
• MalfunctionMar 26, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS HAD CONNECTION ISSUES WITH INTERLINK SOLUTION SETS. THE RETRACTABLE COLLAR DID NOT STAY ENGAGED UPON CONNECTION; THE RING THAT LOCKS IN PLACE WOULD "UNSCREW". THIS WAS DISCOVERED DURING USE; HOWEVER, PATIENT INVOLVEMENT WAS NOT SPECIFIED. 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 21702506 ↗
• MalfunctionMar 5, 2025Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT THE LUER LOCK END OF A CLEARLINK SYSTEM EXTENSION SET WAS "STUCK" IN A LOWERED POSITION AND WOULD NOT ALLOW THE USER TO MAKE A CONNECTION OR TIGHTEN THE CONNECTION BETWEEN SETS. THIS WAS IDENTIFIED DURING USE OF THE SET; HOWEVER, PATIENT INVOLVEMENT WAS NOT SPECIFIED. 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 21526546 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM THE LUER LOCK VALVE EVEN THOUGH THE LINE WAS CLAMPED. THIS WAS OBSERVED DURING A GRAVITY FEED. 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 21526266 ↗
• MalfunctionMar 5, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET DISCONNECTED "AT THE END OF VALVE AND TUBING". THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525878 ↗
• MalfunctionFeb 24, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE MALE LUER ADAPTER COLLAR OF AN UNSPECIFIED QUANTITY OF CLEARLINK LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK, EXTENSION SETS SEEMED TO BE ABNORMALLY DIFFICULT TO MOVE WHICH RESULTED IN A DIFFICULTY TO CONNECT THE SET THE PATIENT¿S CATHETER. THIS ISSUE WAS FURTHER DESCRIBED AS, WHILE CONNECTING THE LUER, MOST TIMES THEY COULD NOT GET THE CATHETER HUB ATTACHED TO THE SET BECAUSE THE SCREW DOWN ATTACHMENT WAS STUCK AND WOULD NOT COME DOWN. THIS ISSUE WOULD OCCUR WHILE ATTEMPTING TO ATTACH THE TUBING TO THE PATIENT'S CATHETER HUB IMMEDIATELY AFTER SUCCESSFULLY PLACING THE IV CATHETER IN THE VEIN. 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 21446935 ↗
• MalfunctionFeb 24, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE MALE LUER ADAPTER COLLAR OF AN UNSPECIFIED QUANTITY OF CLEARLINK LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK, EXTENSION SETS SEEMED TO BE ABNORMALLY DIFFICULT TO MOVE WHICH RESULTED IN A DIFFICULTY TO CONNECT THE SET THE PATIENT¿S CATHETER. THIS ISSUE WAS FURTHER DESCRIBED AS, WHILE CONNECTING THE LUER, MOST TIMES THEY COULD NOT GET THE CATHETER HUB ATTACHED TO THE SET BECAUSE THE SCREW DOWN ATTACHMENT WAS STUCK AND WOULD NOT COME DOWN. THIS ISSUE WOULD OCCUR WHILE ATTEMPTING TO ATTACH THE TUBING TO THE PATIENT'S CATHETER HUB IMMEDIATELY AFTER SUCCESSFULLY PLACING THE IV CATHETER IN THE VEIN. 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 21445874 ↗
• MalfunctionSep 3, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET HAD A LUER ADAPTER THAT WOULD NOT "SLIDE UP TO SCREW ON TO WHAT IT NEEDED TO CONNECT TO". 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 Consequences Or Impact To Patient

  MAUDE report 10491707 ↗
• MalfunctionMay 15, 2019Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THERE WAS A DISCONNECTION ISSUE WITH AN UNSPECIFIED QUANTITY OF CLEARLINK STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS. THE REPORTER STATED THAT THEY COULD NOT REMOVE THE CAP OFF THE END. 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 8612855 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2026 · Aug 29, 2025 · Open, Classified
  CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code