ICU Medical B9449Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709013902), received between Sep 4, 2024 and Oct 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

54 other recalls cover devices cleared under the same FDA submission (K983559); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A 99" (251 CM) 20 DROP Y-TYPE BLOOD SET W/200 MICRON FILTER, HAND PUMP, 2 CLAVE®, ROTATING LUER WHERE IT WAS REPORTED THAT THE LITTLE DRIPPER GETS AIR IN BLOOD SET, HARD TO PRIME AND INFUSE BLOOD PRODUCTS. THE MEDICATION BEING USED WITH THIS IS ALBUMIN. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM OR ADVERSE EVENTS. THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292059 ↗
• MalfunctionSep 4, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 99" (251 CM) 20 DROP Y-TYPE BLOOD SET W/200 MICRON FILTER, HAND PUMP, 2 CLAVE®, ROTATING LUER WHERE IT WAS REPORTED THE SPIKE ON THE ICU MEDICAL TUBING IS CLOTTING OFF. WHEN THIS HAPPENS, IT CAUSES A VACUUM IN THE TUBING THAT DOESN¿T ALLOW THE BLOOD PRODUCTS TO MOVE FORWARD TO THE PATIENT; THE BULB FOR SQUEEZING COLLAPSES. IT WAS REPORTED THE EVENT HINDERED AND SLOWED THE TRANSFUSION PROCESS, AND A WASTAGE OF BLOOD PRODUCTS DUE TO HAVING TO SWITCH TO FRESH BLOOD Y TYPED TUBING. THE EVENT OCCURRED WHILE ACTIVELY TRYING TO TRANSFUSE PACKED RED BLOOD CELLS TO PATIENTS IN THE OPERATING ROOM. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983559. One submission often covers many models, so check the product and lot details in each record.

• Z-0711-2021 · Aug 31, 2020 · Open, Classified
  26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
• Z-2606-2018 · Jul 31, 2017 · Terminated
  119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a
• Z-2638-2018 · Jul 31, 2017 · Terminated
  162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory
• Z-2612-2018 · Jul 31, 2017 · Terminated
  218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is
• Z-2648-2018 · Jul 31, 2017 · Terminated
  143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave, Luer Lock, Sterile The blood tubing accessory wit
• Z-2634-2018 · Jul 31, 2017 · Terminated
  164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave Clear, Rotating Luer, 1 Ext, Sterile The blood t
• Z-2615-2018 · Jul 31, 2017 · Terminated
  112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic
• Z-2629-2018 · Jul 31, 2017 · Terminated
  132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use
• Z-2611-2018 · Jul 31, 2017 · Terminated
  32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic devic
• Z-2657-2018 · Jul 31, 2017 · Terminated
  116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile
• Z-2633-2018 · Jul 31, 2017 · Terminated
  125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, s
• Z-2658-2018 · Jul 31, 2017 · Terminated
  120" (305 cm) 10 Drop Primary Set w/2 MicroClave, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector
• Z-2646-2018 · Jul 31, 2017 · Terminated
  132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a
• Z-2642-2018 · Jul 31, 2017 · Terminated
  100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a sing
• Z-2645-2018 · Jul 31, 2017 · Terminated
  98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single

…and 39 more.