ICU Medical B90115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709012561), received between Jul 7, 2025 and Jul 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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.

• InjuryJul 7, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A COMPLAINT WAS RECEIVED REGARDING A 360" EXT SET W/CLAVE¿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

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension

  MAUDE report 22419836 ↗

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-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV 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-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-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-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• Z-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• 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-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• 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-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50

…and 173 more.