INTERLINK 2C6750HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00085412073583), received between Dec 29, 2017 and Feb 20, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHAMBER (BLOOD FILTER) OF AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. THE ISSUE WAS NOTICED WHILE ADMINISTERING PRBC (PACKED RED BLOOD CELLS). 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 24401198 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED NEAR THE FILTER AND SOLUTION DRIPPED ON THE GROUND. THIS WAS OBSERVED AT A 15 MINUTE CHECK DURING PATIENT INFUSION WITH PLATELETS. THE TUBING WAS DISCONNECTED AND REMOVED FROM THE PATIENT 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 24350250 ↗
• MalfunctionJan 23, 2026

  RN ADMINISTERING PRBC [PACKED RED BLOOD CELLS] NOTED THAT CHAMBER OF BLOOD TUBING LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160700 ↗
• MalfunctionJan 20, 2026

  NO HARM TO PATIENT. PLATELETS WERE PRIMED AND HUNG ON PATIENT. AT 15 MINUTE CHECK, TUBING NEAR FILTER LEAKING AND DRIPPING ON TO GROUND. TUBING DISCONNECTED AND REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114680 ↗
• MalfunctionJan 8, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS LEAKED BLOOD SHORTLY AFTER THE BLOOD TRANSFUSION STARTED ON A PATIENT. THERE APPEARED TO BE A HOLE IN THE TUBING. THE TRANSFUSION WAS STOPPED AND NEW BLOOD TUBING WAS USED TO CONTINUE TREATMENT. 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 21107681 ↗
• MalfunctionOct 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING RIGHT ABOVE THE CHAMBER WHERE THE BLOOD AND SALINE TUBING MEET. A SLOW TRICKLE OF BLOOD WAS SEEN SEEPING FROM THE TUBING. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP AND WAS UNKNOWN IF A PATIENT WAS INVOLVED. 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 18039737 ↗
• MalfunctionJun 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS DEFECTIVE; THE TUBING DETACHED AND THE FILTER WAS BROKEN. THIS WAS DISCOVERED 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 17129259 ↗
• MalfunctionOct 17, 2022Backflow; Mechanical Problem; Backflow; Mechanical Problem

  IT WAS REPORTED THAT THE ROLLER CLAMPS OF THREE (3) INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS ON THE SALINE SIDE WOULD NOT APPLY ADEQUATE PRESSURE TO THE TUBING WHICH RESULTED IN A LEAK/BACKFLOW INTO THE BLOOD BAG. 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 15620627 ↗
• MalfunctionDec 16, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT THE SOFT FILTER OF FOUR (4) INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WAS CLOGGING AND SLOWED THE FLOW. THE 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 13015589 ↗
• MalfunctionNov 24, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT THERE WAS A DELAY IN BLOOD TRANSFUSION WHILE USING AN INTERLINK Y-TYPE BLOOD/SOLUTION SET. THE REPORTER INDICATED THAT THE SET HAD SLOW FLOW, WHICH LED TO THE BLOOD TRANSFUSION TAKING OVER FOUR HOURS. THIS ISSUE OCCURRED DURING PATIENT BLOOD TRANSFUSION. 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 12871636 ↗
• MalfunctionNov 24, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT THERE WAS A DELAY OF BLOOD GETTING TRANSFUSED WHILE USING TWO (2) INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS. THIS ISSUE OCCURRED DURING PATIENT BLOOD TRANSFUSION. 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 12870666 ↗
• MalfunctionNov 16, 2021No Flow; No Flow

  IT WAS REPORTED THAT THE SOFT FILTER OF FOUR (4) INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE CLOGGING AND IMPENDING THE BLOOD FROM FLOWING THROUGH. THIS WAS MOSTLY OBSERVED WHEN TRYING TO INFUSE RAPIDLY WITH A PRESSURE BAG AND SQUEEZING. THIS ISSUE OCCURRED DURING PATIENT BLOOD TRANSFUSION. 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 12822583 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT PLATELETS WERE LEAKING COMING FROM A HOLE IN THE TUBING OF INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET. THIS 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 Consequences Or Impact To Patient

  MAUDE report 9416985 ↗
• MalfunctionJun 8, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT BLOOD TUBING SPIKE OF AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS DISLODGED FROM THE BLOOD TUBING. THIS EVENT OCCURRED DURING PREPARATION AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7582459 ↗
• MalfunctionMay 21, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED AND/OR DISCONNECTED DURING AN UNKNOWN PROCESS STEP. 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 7530034 ↗
• MalfunctionMay 18, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INTERLINK Y-TYPE BLOOD/SOLUTION SETS WERE ¿LEAKING AND/OR DISCONNECTING¿ AT THE END CAPS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527906 ↗
• MalfunctionJan 4, 2018Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT AN INTERLINK (B)(6) BLOOD/SOLUTION SET WAS UNABLE TO PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7164663 ↗
• MalfunctionDec 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED AN AIR IN LINE ALARM OCCURRED ON A SIGMA SPECTRUM PUMP WHILE USING AN INTERLINK BLOOD RECIPIENT SET. THIS EVENT OCCURRED DURING PATIENT INFUSION. BLOOD WAS DRIPPING FREELY, BUT WHEN PLACED ON THE IV PUMP, IT WOULD CONSTANTLY BEEP AND SAY ¿AIR IN LINE¿. THERE WAS NO VISIBLE ISSUE WITH THE TUBING THAT THEY COULD SEE, THERE WAS NO AIR IN LINE, THE PUMP APPEARED TO BE CLEAN AND IN GOOD WORKING ORDER. THE ISSUE WAS RESOLVED AFTER THEY HAD CHANGED THE TUBING. THE PUMP WOULD BEEP WITH THE AIR IN LINE ALARM WITHIN A MINUTE OF STARTING THE INFUSION. ALL CONNECTIONS WERE CHECKED TO ENSURE THEY WERE SECURE PRIOR TO 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 7155431 ↗

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-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-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-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-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-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
• 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-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