ICU Medical B9126Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709013025), received between Dec 20, 2018 and Mar 5, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Flow” (2 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.

• MalfunctionMar 5, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOVLED A 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER, FILTER CAP WHERE IT WAS REPORTED THE DRIP CHAMBER WAS FILLING. THE CUSTOMER STATED THAT THE EMPLOYEES CLAMPED WELL WHEN ADMINISTERING THE MEDICATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836476 ↗
• MalfunctionNov 9, 2023No Flow; No Flow

  THE INCIDENT INVOLVED A 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER, FILTER CAP ON AN UNKNOWN DATE. AS PER REPORT, A SYRINGE PUMP TUBING WAS CONNECTED TO THE PROXIMAL SITE WITH PROPOFOL DURING INFUSION. AT THE SAME TIME, THE ANESTHESIOLOGIST INJECTED THE PROPOFOL BOLUS AT THE 2ND SITE DURING INDUCTION. THE PROPOFOL IMMEDIATELY MOVED UP TO THE SOLUTE SO, THEY HAD TO CLAMP THE TUBING TO ENSURE THAT THE MEDICATION WAS DIRECTED TO THE PATIENT. ONCE THE PATIENT WAS INDUCED, THEY INJECTED THE ANTIBIOTIC VIA THE DISTAL SITE AND THE SAME PROBLEM OCCURRED (I.E. A RETURN TO THE SOLUTE). THE PRIMARY SOLUTE WAS CONNECTED TO A 20G GAUGE PERIPHERAL PERMEABLE CHANNEL. IT SHOULD BE NOTED THAT THE PROBLEM WAS NOT REPEATED WITH SUBSEQUENT INJECTIONS. THE CONTINUOUS INFUSION OF PROPOFOL DID NOT FLOW BACK TO THE SOLUTE AT ANY TIME EITHER. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105754 ↗
• MalfunctionJul 11, 2023Backflow; No Flow; Backflow; No Flow

  THE EVENT INVOLVED A 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER, FILTER CAP, WHERE IT WAS REPORTED THE TUBING WITH BLUE ANTI-REFLUX VALVE IS NOT COMPLIANT SINCE THE LIQUID GOES BACK INTO THE TUBING. THIS CREATES A CHANGE IN THE DOSAGE OF THE MEDICATION TO BE RECEIVED. WHEN USING PROPOFOL, THE SOLUTION WAS BACKING UP IN THE TUBE. THE ERROR COULD BE CAUGHT BECAUSE PROPOFOL IS WELL DIFFERENTIATED WITH ITS MILKY HUE. THEY WERE MADE AWARE OF THE PROBLEM DURING THE PATIENT INDUCTION PERIOD WHILE INJECTING THE DRUG THROUGH THE CLAVE OF THE TUBING. THERE WAS NO BLOOD LOSS. THE TUBING WAS REPLACED AND THERAPY STARTED. TUBING HAD TO BE REMOVED FROM OPERATIONAL CIRCULATION. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299227 ↗
• MalfunctionDec 20, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER THAT THE SOLUTION INVOLVED WAS 1L SODIUM CHLORIDE. THERE WAS NO ADVERSE EVENT. IT WAS ALSO STATED THAT THE NURSE WAS ABLE TO REACT IMMEDIATELY WHEN THE EVENT WAS NOTICED AND CORRECTED THE FLOW RATE AND ADJUSTED IT BY HAND. IT WAS ALSO ADDED THAT 9 INSTANCES OF THIS ISSUE OCCURRED WITH THE SAME PATIENT ON THIS DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8186303 ↗

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-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-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-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• 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-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-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• 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-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

…and 173 more.