CLEARLINK 2C8720Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412049083), received between Mar 15, 2018 and Feb 3, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

10 other recalls cover devices cleared under the same FDA submission (K993120); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Backflow; Filling Problem; Backflow; Filling Problem

  IT WAS REPORTED THAT THERE WAS BACKFLOW OF TRANSFUSION BLOOD WHILE USING A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET. THIS WAS FURTHER DESCRIBED AS "WHILE INFUSING BLOOD THE ROLLER CLAMPS ON THE Y-TUBE FAILED ALLOWING THE BACKFLOW OF THE BLOOD INTO THE 0.9% NS (NORMAL SALINE) BAG AS WELL AS ALLOWING 0.9% NS TO LEAK INTO THE BLOOD ADMINISTRATION INCREASING THE TOTAL VOLUME OF INFUSED FLUID." THIS ISSUE WAS IDENTIFIED DURING A PATIENT BLOOD 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 13446582 ↗
• MalfunctionNov 14, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET CAME APART DURING PATIENT INFUSION. 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 9323701 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT A CLEARLINK Y-TYPE BLOOD/SOLUTION SET HAD A HOLE MIDWAY DOWN THE TUBING. THIS WAS NOTED DURING A PLATELET TRANSFUSION, AND LED TO PLATELETS LEAKING. THIS EVENT INVOLVED A (B)(6) YEAR-OLD FEMALE PATIENT, 105.5 KG. THE PATIENT IS WHITE AND NOT HISPANIC/LATINO. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839623 ↗
• MalfunctionOct 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. IT WAS REPORTED THAT TWO CLEARLINK Y-TYPE BLOOD/SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8015327 ↗
• MalfunctionMar 15, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET DISCONNECTED. APPROXIMATELY THIRTY MINUTES INTO A STEM CELL TRANSPLANT, THE SET DISCONNECTED AND LEAKED. 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 7341867 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993120. One submission often covers many models, so check the product and lot details in each record.

• Z-0193-05 · Apr 28, 2004 · Terminated
  Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows
• Z-1171-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL 60015 U
• Z-1161-03 · Jul 16, 2003 · Terminated
  Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxte
• Z-1172-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C
• Z-1176-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Dee
• Z-1160-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Cor
• Z-1177-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter He
• Z-1175-03 · Jul 16, 2003 · Terminated
  Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthc
• Z-1178-03 · Jul 16, 2003 · Terminated
  Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C7784; Baxter Healt
• Z-1162-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Mal