INTERLINK 2C6720Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412004006), received between Jun 25, 2020 and Oct 2, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET LEAKED ON THE BENCH TOP. THIS WAS OBSERVED DURING SET UP, AFTER COMPLETION OF THE FILTERING PROCESS WITH BLOOD PRODUCT. A PART OF THE CHAMBER APPEARED TO NOT BE PROPERLY GLUED WHICH RESULTED IN TWO DROPS LEAKING THROUGH THE FILTER. THIS WAS OBSERVED AT THE PART OF THE FILTER WHERE THE INLET TUBING ATTACHES TO THE TOP OF THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355132 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET LEAKED IN THE Y-TUBING BY THE FILTER. THIS WAS DISCOVERED DURING PATIENT INFUSION OF BONE MARROW PRODUCT. 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 17126036 ↗
• MalfunctionJun 25, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A Y-TYPE BLOOD/SOLUTION SET SEPARATED FROM THE SPIKE AND RESULTED IN A LEAK. THIS WAS FURTHER DESCRIBED AS THE END OF THE CLEAR TUBING THAT WENT INTO THE WHITE, HARD, PLASTIC END CAME COMPLETELY OUT. THIS WAS IDENTIFIED DURING A BLOOD TRANSFUSION TO A PATIENT. THE OUTCOME WAS THAT THE BLOOD TRANSFUSION WAS RESCHEDULED FOR THE PATIENT¿S NEXT TREATMENT. 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 10197186 ↗

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-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-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-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-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-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-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-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