ICU Medical B9611Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709014657), received between Apr 3, 2025 and Mar 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED DIFFICULTIES WITH CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM WHEN PREPARING CYTOTOXIC OILY DRUGS (PACLITAXEL, DOCETAXEL, ETOPOSIDE) ACROSS ALL DEVICES USED IN RECENT MONTHS. SPECIFICALLY, THE MALFUNCTION RESULTED IN DRUG LEAKAGE. THE SPILL DID NOT INVOLVE THE PATIENT, HOWEVER, THE SPILL CAME INTO CONTACT WITH THE HEALTHCARE WORKER. THE DEVICE ADDITIONALLY FAILED TO EQUALIZE THE PRESSURE INSIDE THE VIAL, PREVENTING THE CORRECT AMOUNT OF MEDICATION FROM BEING DRAWN. ALTHOUGH THERE WERE NO INJURIES OR DEATHS RELATED TO THE MALFUNCTION, THE ISSUE RESULTED IN DELAYS IN THE PREPARATION OF THERAPY. NO MEDICAL INTERVENTION WAS REQUIRED. THE AFFECTED DRUGS HAVE BEEN REPLACED. THE SPILLED MATERIAL WAS CLEANED ACCORDING TO FACILITY PROTOCOL, A SPECIFIC KIT WAS NOT USED. THE ACTUAL SPECIFIC EVENT DATE WAS NOT PROVIDED. THERE WAS NO HUMAN HARM.

  Patient problems: Chemical Exposure

  MAUDE report 24619854 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOCLAVE VENTED VIAL SPIKE IN WHICH IT WAS REPORTED THAT THEY HAVE BEEN EXPERIENCING LEAKAGE WHEN DRAWING FROM VIALS EQUIPPED WITH THIS DEVICE. THE PRESSURE BALANCING DOES NOT WORK PROPERLY WITH THE AIR INTAKE, RESULTING IN PERSISTENT PRESSURE INSIDE THE VIALS. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PRIMING, THERE WAS UNPROTECTED CHEMO EXPOSURE FOR THE HEALTH PROFESSIONAL. THE ADVERSE OPERATOR CONSEQUENCES WERE NOT SPECIFIED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM, BUT THERE WAS DELAY IN CRITICAL THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 23879375 ↗
• MalfunctionJun 30, 2025Particulates; Particulates

  THE EVENT INVOLVED A CHEMOCLAVE VENTED VIAL SPIKE, 20MM WHERE PARTICLES WERE REPORTED IN AN INFUSION BAG USING DOSTARLIMAB IN A CLINICAL STUDY. THE PREPARED INFUSION CONTAINED MANY SMALL WHITE PARTICLES. A REPORT HAS ALREADY BEEN MADE FOR THE PRODUCT DOSTARLIMAB, BUT THIS TIME IT CONCERNED A DIFFERENT STUDY (AZUR-2, PROTOCOL 219606, SPONSOR GLAXOSMITHKLINE PHARMACEUTICALS). INFUSION WAS PREPARED A SECOND TIME WITH NEW DOSTARLIMAB VIALS BUT WITHOUT THE USE OF CHEMOCLAVE, I.E. WITH SYRINGE AND NEEDLE AND NO PARTICLES WERE OBSERVED. THE PHARMACY MANUAL OF THIS STUDY STATES THAT THIS PRODUCT MAY BE PREPARED WITH CHEMOCLAVE, SO IT WAS ASSUMED THAT COMPATIBILITY TESTS HAVE ALREADY BEEN PERFORMED. THE EVENT OCCURRED DURING RECONSTITUTION OF THE IMP. THE EVENT WAS DETECTED PRIOR TO DIRECT PATIENT USE. PATIENT WAS NOT HARMED, INFUSION BAG WITH PARTICLES WAS NOT DISPENSED NOR ADMINISTERED. THERE WAS A DELAY IN CRITICAL THERAPY. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. NG DEVICE(S) AVAILABLE TO BE TESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22362451 ↗
• MalfunctionJun 24, 2025Particulates; Particulates

  THE REPORTED COMPLAINT INVOLVED A CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM. PARTICLES WERE REPORTED IN AN INFUSION BAG USING PEMBROLIZUMAB (FROM FOREIGN DISTRIBUTOR SERVIER BULGARIA) IN NACL 0.9% 100 ML INFUSION DURING A CLINICAL STUDY. THE PARTICLES FORMED UPON TIME OF DILUTION OF THE CONCENTRATED PEMBROLIZUMAB INTO A SALINE INFUSION BAG. INFUSION WAS PREPARED A SECOND TIME WITH NEW PEMBRO VIALS, WHEREBY PARTICLES WERE OBSERVED AGAIN. INFUSION WAS PREPARED A THIRD TIME, THIS TIME WITH SYRINGE AND NEEDLE AND NO PARTICLES OBSERVED. NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE. NO ADVERSE OPERATOR CONSEQUENCES. NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE INVOLVED PATIENT WAS NOT HARMED, THERE WAS ONLY DELAY OF THERAPY AND INFUSION BAG WITH PARTICLES WAS NOT DISPENSED NOR ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324563 ↗
• MalfunctionApr 17, 2025Particulates; Particulates

  ADDITIONAL INFORMATION WAS RECEIVED ON STATING THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED. NO PHYSICAL DAMAGE WAS NOTICED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862619 ↗
• MalfunctionApr 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM. THE REPORTER STATED THAT PARTICLES WERE OBSERVED AFTER PREPARATION OF PERJETA (PERTUZUMAB) VIAL 420MG/14ML À 420MG DILUTE IN 100ML NACL 0.9%. THIS ALSO WAS OBSERVED WITH ¿STUDY MEDICATIONS¿ THAT THEY BEEN PREPARING FOR A LONGER TIME. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768832 ↗
• MalfunctionApr 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED ON 08-APR-2025. THE REPORTER STATED THAT, AFTER PREPARATION PARTICLES ARE VISIBLE IN THE IV BAG. THE PROBLEM OCCURRED IN (B)(6) 2025. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. IT WAS DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS A DELAY IN CRITICAL THERAPY. NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767751 ↗
• MalfunctionApr 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION WAS RECEIVED WHERE THE CUSTOMER STATED THAT AFTER PREPARATION PARTICLES ARE VISIBLE IN THE IV BAG. THEY STUDY CHEMO FOR NEW DRUG THAT IS NOT ALREADY ON THE MARKET. THEY ARE NOT SURE WHICH OF THE DEVICE CAN BE THE CAUSE OF THOSE PARTICLES BUT THEY ARE ASSUMING THAT IT COULD BE THE SILICONE OIL. THERE WAS NO SERIOUS INJURY, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES, AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. IT WAS DETECTED PRIOR TO DIRECT PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767689 ↗

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-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-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• 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-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• 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-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908

…and 173 more.