ICU Medical B2163Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709003576), received between Apr 5, 2022 and Apr 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Leak/Splash

  PER THE REPORT RECEIVED, THE PATIENT WAS GETTING A BLOOD TRANSFUSION THROUGH THE IV TUBING. ABOUT 50 MINUTES INTO THE TRANSFUSION, THE REGISTERED NURSE (RN) NOTICED SOME BLOOD SPLATTER ON THE FLOOR NEXT TO THE ISOLETTE NEONATAL INCUBATOR. THE RN THEN EXAMINED THE SET UP OF THE TRANSFUSION, AND NOTICED THAT THERE WAS A LEAK COMING FROM THE EXTENSION TUBING, ICU MEDICAL B2163. RN THEN CHANGED THE TUBING, AND THE NEW TUBING WAS LEAKING IN THAT SAME SPOT. SHE CHANGED THE TUBING ONCE MORE, AND IT WAS STILL LEAKING IN THAT SAME AREA OF THE TUBING. SHE THEN CHANGED OUT THE INFUSION PUMP AND GOT DIFFERENT TUBING TO COMPLETE THE TRANSFUSION. HEALTH CARE PROVIDERS DO NOT HAVE A LOT OF INFO, BUT THE IV TUBING THAT LEAKED IS AVAILABLE IF THE MANUFACTURER WANTS TO EXAMINE THEM.

  Patient problems: Insufficient Information

  MAUDE report 14013650 ↗

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-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-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-0222-2021 · Jul 6, 2020 · Terminated
  123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The In
• Z-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• 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-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0217-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)

…and 173 more.