CLEARLINK 2C8634Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412049021), received between Apr 23, 2020 and Apr 15, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Aug 29, 2025Open, Classified

   IV sets may leak.

   Z-0199-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionApr 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A STRAIGHT-TYPE EXTENSION SET "CAME APART" DURING INFUSION OF UNSPECIFIED FLUIDS. THE PATIENT WAS USING THE RESTROOM PRIOR TO SURGERY. WHEN STAFF RETURNED TO ESCORT THE PATIENT BACK TO THE ROOM, THE TUBING WAS FOUND TO HAVE COME APART, WITH "MINIMAL" BLOOD OBSERVED ON THE BATHROOM FLOOR. STAFF PROMPTLY CLAMPED THE TUBING NEAR THE PATIENT, FLUSHED THE IV LINE, AND REPLACED THE TUBING AND IV BAG. 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 24888470 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET SPLIT (SEPARATED) IN TWO PIECES. THIS WAS OBSERVED DURING AN APHERESIS PROCEDURE. THE PATIENT WAS ACCESSED WITH A 16G NON-BAXTER HIGH-FLOW NEEDLE. AT THE END OF THE PROCEDURE, THE NURSE PLACED A NON-BAXTER CONNECTOR AND FLUSHED THE LINE WITHOUT ISSUES. WHEN THE NURSE RETURNED TO THE ROOM APPROXIMATELY 10 MINUTES LATER, THE EXTENSION SET SPLIT IN TWO PIECES, LEAVING THE PORT OPEN TO AIR. THE NURSE IMMEDIATELY INSERTED THE ONE END BACK INTO THE OTHER AND ASPIRATED ANY AIR THAT MAY HAVE BEEN IN THE LINE. THE PORT NEEDLE WAS THEN REMOVED PER PROTOCOL. 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 20260969 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK LUER ACTIVATED VALVE EXTENSION SETS LEAKED FROM THE LUER LOCK HUB THAT CONNECTS TO THE IV CATHETER SYSTEM. THE LUER LOCK IS NOT COMPLETELY SEATED AND WILL NOT MOVE PAST THE FIRST THREAD. 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 19233559 ↗
• MalfunctionFeb 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK EXTENSION SETS LEAKED; FURTHER DESCRIBED AS "LEAKING AT THE LUER LOCK HUB THAT CONNECTS TO THE IV CATHETER SYSTEM." THIS WAS OBSERVED DURING USE OF THE PRODUCT; HOWEVER, PATIENT INVOLVEMENT IS NOT SPECIFIED. THE LEAK WAS NOT CORRECTED BY RESEATING THE CONNECTION. A NEW EXTENSION SET WOULD BE PLACED TO RESOLVE THE EVENT. 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 18655944 ↗
• MalfunctionNov 28, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK COLLAR OF TWO (2) CLEARLINK SYSTEM EXTENSION SETS WERE SNAPPED OFF CAUSING A PIECE OF THE SET TO BECAME LODGED INSIDE THE LUMEN OF THE CENTRAL LINE. THIS ISSUE WAS IDENTIFIED DURING INFUSION. THE CENTRAL LINE HAD TO BE REPLACED. 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 15870976 ↗
• MalfunctionOct 12, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM EXTENSION SET SEPARATED FROM THE CONNECTOR WHICH RESULTED IN A LEAK. THE ISSUE WAS IDENTIFIED DURING 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 12614900 ↗
• MalfunctionApr 26, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LUER OF CLEARLINK SYSTEM EXTENSION SET SEPARATED FROM THE TUBING WHICH RESULTED IN A LEAK. THIS WAS OBSERVED DURING 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 11728574 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WAS LEAKING FROM THE CONNECTOR WHEN ATTACHED TO THE INTRAVENOUS (IV) HUB. IT WAS FURTHER REPORTED THAT THE LEAK CONTINUED AS THE NURSE TRIED TO TIGHTEN THE CONNECTION AT THE HUB. THIS WAS NOTED DURING PATIENT USE. THE SET WAS REMOVED TO CONTINUE THERAPY. 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 9990646 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WAS LEAKING FROM THE CONNECTOR WHEN ATTACHED TO THE INTRAVENOUS (IV) HUB. IT WAS FURTHER REPORTED THAT THE LEAK CONTINUED AS THE NURSE TRIED TO TIGHTEN THE CONNECTION AT THE HUB. THIS WAS NOTED DURING PATIENT USE. THE SET WAS REMOVED TO CONTINUE THERAPY. 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 9990644 ↗

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-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-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-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