ICU Medical B2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709002890), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 malfunction.

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

• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 72" (183 CM) APPX 2.1ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT PROPOFOL SQUIRTED IN THE DOCTOR'S EYE AS HE WAS PUSHING IT THROUGH THE TUBING FOR THE PATIENT. THERE IS A SMALL HOLE IN ONE END THAT CONNECTS TO THE SYRINGE. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621899 ↗

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-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-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-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-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-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-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-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0260-2021 · Jul 6, 2020 · Terminated
  124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034
• Z-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche

…and 173 more.