ICU Medical B9041Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709012769), received between Aug 21, 2023 and Aug 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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.

• MalfunctionAug 21, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THE CUSTOMER HAD A TOTAL PARENTERAL NUTRITION (TPN) EXTENSION SET BECOME DISCONNECTED WHILE IN USE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED. THIS IS THE FOURTH OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586095 ↗
• MalfunctionAug 21, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THE CUSTOMER HAD A TOTAL PARENTERAL NUTRITION (TPN) EXTENSION SET BECOME DISCONNECTED WHILE IN USE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED. THIS IS THE SECOND OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585306 ↗
• MalfunctionAug 21, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THE CUSTOMER HAD A TOTAL PARENTERAL NUTRITION (TPN) EXTENSION SET BECOME DISCONNECTED WHILE IN USE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED. THIS IS THE FIRST OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585303 ↗
• MalfunctionAug 21, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THE CUSTOMER HAD A TOTAL PARENTERAL NUTRITION (TPN) EXTENSION SET BECOME DISCONNECTED WHILE IN USE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED. THIS IS THE THIRD OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585302 ↗

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-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-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-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-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-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• Z-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• Z-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01

…and 173 more.