ICU Medical B9286Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619045876), received between Jul 7, 2024 and Dec 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Contamination; Contamination

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE, ROTATING LUER WAS FOUND TO BE CONTAMINATED. IT WAS REPORTED THAT THE PRODUCT HAD BEEN CONTAMINATED IN THE FLUID PATH. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855521 ↗
• MalfunctionMay 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A COMPLAINT WAS RECEIVED REGARDING A TO 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE¿, ROTATING LUER THAT EXPERIENCED PARTICULATE MATTER IN THE FLUID PATH. IT WAS REPORTED THAT THEY HAVE A CONTAMINATED ITEM. PHOTO OF THE ACTUAL DEFECTIVE ITEM WAS PROVIDED. BOTH LOT NUMBERS 14246714 AND 14224719 ARE IN CONTENTION FOR CONTAINING THE COMPROMISED IV TUBING. THESE WERE THE TWO OPENED PACKAGES FOR THE PREOP SUITE IN THE TRASH. THE PRIMARY NURSE WAS UNABLE TO IDENTIFY WHICH OF THE TWO LOT NUMBERS CONTAINED THE DEFECTIVE TUBING. THE DATE OF INCIDENT WAS ON (B)(6) 2025. THE PRIMARY NURSE DID NOT NOTICE THE PROBLEM WHILE PRIMING THE FLUIDS. DURING THE FLUIDS INFUSION, THE SECONDARY NURSE NOTICED THE PROBLEM. THE PATIENT INVOLVED WAS RECEIVING THE IV FLUIDS PRIOR TO STOPPING THE INFUSION TO EVALUATE THE DEFECT WHEN A SECONDARY NURSE OBSERVED THE PROBLEM. THE SECONDARY NURSE WAS UNABLE TO REMOVE IT FROM THE OUTSIDE OF THE DEVICE WITH AN ALCOHOL SWAB AND UNHOOKED THE PATIENT AND GOT AN ENTIRE NEW LINE SET OF A DIFFERENT MANUFACTURER AND INITIATED IV THERAPY. AFTERWARDS, THE SECONDARY NURSE ATTEMPTED TO OPEN THE INSIDE AND DETERMINE IF IT WAS ON THE INSIDE OF THE TUBING BUT COU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21956590 ↗
• MalfunctionMay 2, 2025Particulates; Particulates

  THE EVENT INVOLVED A 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE¿, ROTATING LUER WITH POSSIBLE LOT NUMBERS 14246714 AND 14224719 WHERE IT WAS REPORTED THAT THE CUSTOMER HAD A CONTAMINATED ITEM. THE PRIMARY NURSE DID NOT NOTICE THE PROBLEM WHILE PRIMING THE FLUIDS. DURING THE FLUIDS INFUSION, THE SECONDARY NURSE NOTICED THE PROBLEM. THE PATIENT INVOLVED WAS RECEIVING THE IV FLUIDS PRIOR TO STOPPING THE INFUSION TO EVALUATE THE DEFECT WHEN A SECONDARY NURSE OBSERVED THE PROBLEM. THE SECONDARY NURSE WAS UNABLE TO REMOVE IT FROM THE OUTSIDE OF THE DEVICE WITH AN ALCOHOL SWAB AND UNHOOKED THE PATIENT AND GOT AN ENTIRE NEW LINE SET OF A DIFFERENT MANUFACTURER AND INITIATED IV THERAPY. AFTERWARDS, THE SECONDARY NURSE ATTEMPTED TO OPEN THE INSIDE AND DETERMINE IF IT WAS ON THE INSIDE OF THE TUBING BUT COULD NOT REMOVE THE DEFECT BY ANY MEANS OF SANITIZATION. NO IMMEDIATE HARM TRANSPIRED TO THE PATIENT THAT WAS OBSERVED WHILE IN CARE AT THE SURGERY CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950374 ↗
• MalfunctionJul 7, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER. THE REPORT STATED THAT THE TUBING EXPLODED AT THE END OF THE TEST AND THE TUBING HAS 2 ACCESS PORTS NOT 3. THE TUBING OPENED ABOUT 2.5 INCHES ABOVE THE LOWEST ACCESS PORT. THERE DOES NOT APPEAR TO BE ANY BLOOD IN THE TUBE. WHEN THE PATIENT RETURNED TO THE ED, THE TUBING WAS CHANGED OUT AND THE IV WAS STILL USABLE. THEY ONLY HAVE THE TUBING ITSELF. NO OTHER COMPONENTS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686808 ↗

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-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-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-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• Z-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav
• Z-0230-2021 · Jul 6, 2020 · Terminated
  114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per
• 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-0245-2021 · Jul 6, 2020 · Terminated
  126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intrav
• 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-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

…and 173 more.