CLEARLINK 4C8723Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00085412049076), received between Oct 30, 2018 and May 27, 2025 — classified as 1 death, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD A BROKEN LUER LOCK PIECE. THIS OCCURRED WHILE DISCONNECTING THE SET FROM THE INTRAVENOUS (IV) SITE, AFTER A PATIENT INFUSION OF BLOOD PRODUCTS AT A RATE OF 150 ML/HR. 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 22091127 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT THE LUER LOCK PIECE OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET BROKE OFF WHILE DISCONNECTING THE SET FROM THE PATIENT'S INTRAVENOUS (IV) SITE. THE LEUR LOCK BROKE OFF WHILE STILL ATTACHED TO THE PATIENT'S IV ACCESS. THIS OCCURRED DURING THERAPY WITH BLOOD PRODUCTS IN THE INTENSIVE CARE UNIT (ICU). 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 22090697 ↗
• MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING FROM THE AREA WHERE THE HAND PUMP CONNECTS WITH THE CHAMBER. IN THIS EVENT, BLOOD LEAKED THROUGH THE TOP OF THE HAND SQUEEZED PUMP. THE PRESSURE APPLIED TO THE PUMP SPRAYED BLOOD AROUND THAT SIDE OF THE ANESTHESIA/OPERATING ROOM AREA. THE PUMP WAS USED WITH BOTH DONATED BLOOD AND AUTOLOGOUS BLOOD. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955591 ↗
• MalfunctionJul 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING THROUGH THE TOP OF THE PUMP. THE LEAK WAS DISCOVERED DURING USE OF THE DEVICE WITH BLOOD. 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 19697410 ↗
• MalfunctionJul 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING THROUGH THE TOP OF THE PUMP. THE LEAK WAS DISCOVERED DURING USE OF THE DEVICE WITH BLOOD. 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 19697296 ↗
• MalfunctionMay 22, 2024Crack; Crack

  IT WAS REPORTED THAT THE INLINE PRESSURE PUMP OF TWO (2) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS CRACKED. THIS OCCURRED WHILE SQUEEZING THE PUMP TO INFUSE FLUID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374663 ↗
• MalfunctionDec 10, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AT LEAST THREE (3) UNITS OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD A CRACK AND LEAKS. THE ISSUE WAS IDENTIFIED 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 12976663 ↗
• Jun 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. DURING OPEN HEART SURGERY, CELL SAVER WAS BEING ADMINISTERED AFTER THE PATIENT WAS COMING OFF CARDIOPULMONARY BYPASS (CPB). AFTER SPIKING THE CELL SAVER, THE NURSE UTILIZED THE PRESSURE PUMP AND NOTICED THAT BLOOD HAD JUST SHOT OUT OVER THEIR SHIRT, PANTS AND THE FLOOR. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE BLOOD SET WAS LEAKING WHERE THE PRESSURE PUMP AND THE PURGE AIR REGULATING CLAMP CONNECT. A NEW SET HAD TO BE PRIMED. 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 12094153 ↗
• MalfunctionJun 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED AT THE TOP OF THE HAND PUMP. THE SET WAS USED WITH NORMAL SALINE. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947992 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRESSURE PUMP OF AN UNSPECIFIED QUANTITY (5-6) OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS LEAKED. THIS ISSUE WAS IDENTIFIED DURING THE INDUCTION OF ANESTHESIA. 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 11752164 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING FROM THE PRESSURE PUMP. THIS ISSUE WAS 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 11717456 ↗
• MalfunctionApr 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 3 CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WERE DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS LEAKED AT THE HAND PUMP. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 11712305 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS LEAK COMING FROM THE TOP OF THE PRESSURE PUMP AT THE SEAM. THIS ISSUE WAS IDENTIFIED DURING PRIMING IN THE ¿OR ROOM¿ PRIOR TO USE ON THE PATIENT. AS A RESULT, A NEW SET WAS OBTAINED FOR 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 11649051 ↗
• MalfunctionApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED FROM THE TOP OF THE PRESSURE PUMP; FURTHER STATED AS COMING FROM THE SEAM. THIS WAS OBSERVED WHILE HOOKED UP TO A PATIENT. 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 11634386 ↗
• MalfunctionApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED FROM THE TOP OF THE PRESSURE PUMP; FURTHER STATED AS COMING FROM THE SEAM. THIS WAS OBSERVED WHILE HOOKED UP TO A PATIENT. 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 11634380 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Defective Component

  ANESTHESIA PROVIDERS REPORTED 5-6 DEFECTIVE PRESSURE PUMPS FROM THE SAME LOT NUMBER. DURING THE INDUCTION OF ANESTHESIA WITH PROPOFOL, THE SETS LEAKED AND SPRAYED LACTATED RINGERS SOLUTION OUT OF THE PRESSURE PUMP COMPONENT, WHERE THE CENTER PLASTIC SECTION OF THE PUMP MEETS THE END PIECE OF THE PUMP. THE Y-TYPE IV SET HAD TO BE SWITCHED OUT FOR ANOTHER SET. BRIEFLY DISRUPTED CRITICAL CARE PROCESS, AND SPRAYED RINGERS SOLUTION ON PROVIDER AND PATIENT. NO KNOWN HARM TO PATIENT OR STAFF. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11472738 ↗
• MalfunctionFeb 2, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET SEPARATED FROM THE SPIKE. THIS WAS IDENTIFIED DURING PRIMING OF A BLOOD BAG WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11269469 ↗
• MalfunctionFeb 2, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET SEPARATED FROM THE SPIKE. THIS WAS IDENTIFIED DURING PRIMING OF A BLOOD BAG WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11269427 ↗
• MalfunctionNov 9, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE LEAKING FLUID AND BLOOD. IT WAS STATED THAT THE SETS FELL APART WHERE ONE OF THE SPIKE CONNECTIONS GO INTO THE FLOW CHAMBER. THIS ISSUE WAS IDENTIFIED DURING PREPARATION PRIOR TO THE START OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10810404 ↗
• MalfunctionJul 21, 2020Component Missing; Component Missing

  DURING EVALUATION A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS RETURNED WITH THE ROLLER CLAMP MISSING. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10302620 ↗
• DeathMar 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO UNITS OF ACCESS BLOOD SOLUTION SETS LEAKED DURING PATIENT USE. THE LEAKS WERE OBSERVED AT THE SIDE OF THE PRESSURE PUMP CHAMBER OF THE SETS WHILE THE PATIENT WAS CONNECTED. IT WAS REPORTED THE PATIENT WAS ON THE WAY TO THE INTENSIVE CARE UNIT AND ¿EVENTUALLY PASSED AWAY¿. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 9897813 ↗
• MalfunctionJul 26, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THREE (3) CLEARLINK BLOOD RECIPIENT SETS LEAKED. THE REPORTER STATED THAT WHEN THE ANESTHESIA CLINICIAN ATTEMPTED TO USE THE HAND PUMP OF A MANUAL BLOOD PUMP IV SET, THE DEVICE SEPARATED BETWEEN THE INFLOW CAP AND THE CYLINDER OF THE HAND PUMP, LEADING TO A LEAK OF BLOOD. THIS OCCURRED PRIOR TO PATIENT USE. THE REPORTER STATED THAT THIS HAD PREVIOUSLY OCCURRED TWO ADDITIONAL TIMES. PROCESS STEP AND PATIENT INVOLVEMENT ARE UNKNOWN FOR THE TWO ADDITIONAL EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833300 ↗
• MalfunctionJul 26, 2019Product Quality Problem; Improper Flow or Infusion; Product Quality Problem; Improper Flow or Infusion

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THE PAPER TIES OF AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE LOOSE AND FELL OFF THE SET. THIS OCCURRED BOTH PRIOR TO PATIENT USE AND DURING PRIMING. THE STAFF REPORTED THAT THIS HAD CAUSED SEVERAL ISSUES INCLUDING: THE LINE DROPPING AND HITTING THE FLOOR WHEN THE PACKAGING WAS OPENED (THE SET HAD TO BE REPLACED), THE LINE BECOMING TANGLED, THE SET BEING DIFFICULT TO HANG ON THE IV POLE, LINES UNRAVELING AND HITTING THE GROUND AFTER PRIMING, AND THE DRIP CHAMBERS BECOMING INVERTED DURING SETUP, LEADING TO AIR GETTING INTO THE LINE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8833166 ↗
• MalfunctionJul 26, 2019Disconnection; Disconnection

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THE TUBING OF A CLEARLINK Y-TYPE BLOOD/SOLUTION SET WAS DETACHED FROM THE DISTAL END OF THE Y-SITE. THIS OCCURRED DURING AN UNKNOWN PROCESS STEP. IT WAS NOT SPECIFIED WHETHER THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8832416 ↗
• MalfunctionApr 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THERE WERE THREE (3) EVENTS OF LEAKING CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS. IN ONE (1) EVENT, ONE SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. IN TWO (2) EVENTS, AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS CAME APART WHERE THE SEAM MEETS THE CHAMBER WHICH RESULTED IN LEAKAGE. FOR ALL THREE (3) EVENT, THE LEAKS WERE OBSERVED DURING PATIENT THERAPY AND THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560564 ↗

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-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-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-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
• 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-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