ICU Medical B30010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709003934), received between Feb 19, 2026 and Sep 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Fluid/Blood Leak

  The event involved a 100 inch (254 cm) Appx 12.3 ml, 15 Drop Admin Set w Rotating Luer. It was reported that customer advised that when priming this set, the y-sites were leaking fluid. After further discussion, customer indicated that the fluid in use was heparinized, pressurized saline. The product was not contaminated or contain a biohazard or chemotherapy agent. There was no delay in therapy. There was no adverse event. No medication was being used with this product. The product was not reprocessed or re sterilized prior to use. There were no patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697160 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  The event involved a 100 inch (254 cm) Appx 12.3 ml, 15 Drop Admin Set w Rotating Luer reported that customer advised that when priming this set, the y-sites were leaking fluid. After further discussion, customer indicated that the fluid in use was heparinized, pressurized saline. The product was not contaminated or contain a biohazard or chemotherapy agent. There were no patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694864 ↗
• MalfunctionMar 5, 2026Free or Unrestricted Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/ROTATING LUER WHERE THE CUSTOMER REPORTED THAT DURING ROUTINE CLINICAL USE, IN A VETERINARY CLINIC, IT WAS OBSERVED THAT MACRODRIP LINES CONTINUE TO FREE-FLOW EVEN WHEN THE PUMP DOOR IS FULLY CLOSED AND THE PUMP IS OPERATING. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521212 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/ROTATING LUER AND IT WAS REPORTED THAT WHEN THE BAG WAS SPIKED, IT WAS LEAKING. THIS IS HAPPENING USUALLY WITHIN 10 MINUTES OF INFUSION; THIS IS BEING UTILIZED FOR THE NEURO CASES. THIS PRODUCT IS USED WITH A PRESSURE BAG. THE LEAKING IS COMING DIRECTLY FROM WHERE THE BAG IS SPIKED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386496 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• Z-0238-2021 · Jul 6, 2020 · Terminated
  11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1
• Z-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• Z-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1

…and 173 more.