CLEARLINK 2C8750Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00085412046341), received between Jan 2, 2018 and Sep 24, 2026 — classified as 1 injury, 175 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (86 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 25 most recent of 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  During evaluation of a CLEARLINK System Y-Type Blood/Solution Set, the spike adapter was observed to be broken. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878518 ↗
• MalfunctionSep 8, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674027 ↗
• MalfunctionSep 8, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674024 ↗
• MalfunctionJun 18, 2026Device Alarm System

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF Y-TYPE BLOOD/SOLUTION SETS WITH STANDARD BLOOD FILTER GENERATED DOWNSTREAM OCCLUSION ALARMS. THE EVENTS WERE IDENTIFIED DURING INFUSION AT RATES ABOVED 899 ML/HOUR ON A NOVUM IQ LVP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553888 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak; Material Puncture/Hole; Failure to Disconnect

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET HAD HOLES IN THE TUBING, RESULTING IN LEAKAGE OF NORMAL SALINE. THE EVENT OCCURRED WHILE THE USER WAS PREPARING TO ADMINISTER A UNIT OF BLOOD. THE USER SPIKED THE NORMAL SALINE BAG AND THEN, THE BLOOD UNIT. DURING PRIMING WITH NORMAL SALINE, FLUID RAPIDLY LEAKED FROM THE TUBING ONTO THE FLOOR. UPON INSPECTION, HOLES WERE IDENTIFIED IN THE TUBING AT THE CLAMP SECTION ON BOTH THE NORMAL SALINE AND BLOOD LINES. THE USER ATTEMPTED TO SWITCH THE UNIT OF BLOOD TO A NEW TUBING; HOWEVER, WAS UNABLE TO REMOVE THE TUBING. DURING FURTHER INSPECTION, THE TUBING LOOKED ¿PERFORATED¿ AND AFTER MANIPULATION, THE TUBING RIPPED LARGER WITH A WHOLE CHUNK OF THE TUBING COMING OFF. A NEW BLOOD UNIT AND TUBING WOULD BE USED TO CONTINUE THE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209694 ↗
• MalfunctionApr 21, 2026Backflow

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER BACKFLOWED DURING PLATELET TRANSFUSION. (B)(4) UNIT (291 ML) OF PLATELETS WAS INTENDED TO INFUSE OVER ONE HOUR. THE STAFF PRIMED BLOOD TUBING WITH SODIUM CHLORIDE 0.9% 500ML BAG AND CLAMPED TUBING CONNECTED TO THE NORMAL SALINE BAG. SPIKED THE PLATELET BAG AND BEGAN TRANSFUSION. NEAR THE END OF THE TRANSFUSION, STAFF NOTED THAT THE PLATELET BAG VOLUME HAD NOT DECREASED AS EXPECTED AND DISCOVERED THAT THE ENTIRE 500 ML SALINE BAG HAD BACKFLOWED INTO THE PLATELET BAG DESPITE THE CLAMP BEING FULLY CLOSED. THE DILUTED PLATELETS WERE TRANSFUSED WITHIN A 4 HOUR TIME FRAME. 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 24945476 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK Y-TYPE BLOOD/SOLUTION SETS WITH STANDARD BLOOD FILTER LEAKED FROM THE MALE LUER. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719878 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET LEAKED FROM THE AREA OF THE SPIKED PORT; FURTHER DESCRIBED FROM THE CONNECTION BETWEEN THE SPIKE AND THE TUBING. THIS WAS OBSERVED 15 MINUTES INTO A PATIENT TRANSFUSION WITH A BLOOD PRODUCT. TO RESOLVE THE EVENT, THE INFUSION WAS STOPPED AND TUBING WAS REPLACED. WHEN THE NURSE TOOK THE UNIT OFF THE INTRAVENOUS (IV) POLE AND WENT TO SWITCH OUT THE TUBING, THE SET AT THAT CONNECTION POINT FELL APART VERY EASILY. 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 24612334 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS LEAKED BLOOD AROUND THE HUB (CLEARLINK), ONTO FLOOR AND WITHIN BLOOD WARMER. THE ISSUE OCCURRED 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 24611807 ↗
• MalfunctionMar 13, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD A VISIBLE CRACK BELOW THE FILTER, LEADING TO A BLOOD LEAK. THE ISSUE OCCURRED WHEN SPIKING THE BLOOD BAG TO PRIME THE SET IN THE PEDIATRIC HEMATOLOGY/ONCOLOGY/BMT MED/SURG UNIT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594861 ↗
• MalfunctionMar 10, 2026Crack

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET HAD A CRACKED LUER-LOCK END PIECE. THIS WAS OBSERVED AFTER OPENING THE PACKAGING. 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 24561270 ↗
• MalfunctionMar 2, 2026Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD BROKEN AWAY FROM THE LUER CONNECTOR THAT WAS CONNECTED TO THE PATIENT'S PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE. THE ISSUE WAS OBSERVED DURING TRANSFUSION OF PLATELETS, WHEN THE PATIENT WAS AMBULATING IN THE HALL. 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 24484957 ↗
• MalfunctionFeb 11, 2026Crack

  IT WAS REPORTED THAT THE Y CONNECTOR OF A CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET HAD A CRACK AT THE HUB. THIS WAS OBSERVED DURING PATIENT 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 24318452 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET WAS ATTACHED TO THE PATIENT¿S LINE. WHEN THE TUBING WAS DISCONNECTED FROM THE PORT AND AN ATTEMPT WAS MADE TO PLACE A GREEN CURO CAP ON THE END OF THE Y TUBING, THE HUB DETACHED FROM THE LINE. 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 24317146 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET SPLIT APART AT THE INSERTION SITE OF THE PRBC (PACKED RED BLOOD CELLS) UNIT AND FLUID SPILLED ONTO THE INFUSION PUMP AND SURROUNDINGS. THE ISSUE WAS NOTICED WHILE DISCONNECTING A PRBC UNIT FROM THE 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 24262138 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET CAME APART DURING PATIENT TRANSFUSION. 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 24251375 ↗
• MalfunctionFeb 3, 2026

  PATIENT WAS AMBULATING IN HALL; RN NOTICED A LINE DRAGGING ON THE FLOOR. PATIENTS' BLOOD TUBING THAT WAS INFUSING PLATELETS HAD BROKEN AWAY FROM LUER CONNECTOR THAT WAS CONNECTED TO THE PATIENTS PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245945 ↗
• MalfunctionJan 30, 2026Protective Measures Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE CAUSING LOADING ISSUES WITH THE NOVUM IQ PUMP. THE LOADING ERROR WAS AT THE AIR BUBBLE SENSOR (SENSOR NUMBER 2). THE DEVICE CONTAINED SALINE. THIS WAS OBSERVED DURING SETUP. 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 24222205 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24214728 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205538 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER EXPERIENCED A SEPARATION ISSUE. WHILE PRIMING THE SET FOR TRANSFUSION, THE HARD PLASTIC BETWEEN THE TUBING AND THE NEAR FILTER SNAPPED OFF. 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 24193697 ↗
• MalfunctionJan 27, 2026Protective Measures Problem

  IT WAS REPORTED THAT MORE THAN TEN (10) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE CAUSING IV PUMPS TO ALARM AIR IN LINE. THIS WAS OBSERVED DURING BLOOD TRANSFUSION. 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 24191089 ↗
• MalfunctionJan 15, 2026False Alarm

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD CONSTANT ALARMS FOR THE PRESENCE OF AIR BUBBLES, WHILE THERE ARE NO AIR BUBBLES. THE ISSUES WERE IDENTIFIED DURING PATIENT INFUSION WITH AN INFUSION PUMP. 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 24089352 ↗
• MalfunctionDec 31, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS HAD CONSTANT ALARMS FOR THE PRESENCE OF AIR BUBBLES, WHILE THERE ARE NO AIR BUBBLES. THE ISSUES WERE IDENTIFIED DURING PATIENT 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 23938216 ↗
• MalfunctionDec 23, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT AN UNSPECIFIED PUMP WAS ALARMING FOR THE PRESENCE OF AIR IN THE LINE OF A CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER. WHEN INSTALLED IN THE INFUSION PUMP, THE DEVICE CONSISTENTLY TRIGGERED AIR-IN-LINE ALARMS DESPITE NO AIR BUBBLES BEING PRESENT. THIS ISSUE OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884747 ↗

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-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-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-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-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-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-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
• 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-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-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