ICU Medical MC33352Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709038004), received between May 16, 2025 and Sep 25, 2026 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Flow

  A reported incident involved a smallbore extension set with a Micro Clave Clear connector. It was reported that, a dose of ceftaroline was connected to the extension set; however, the medication could not be flushed through the tubing. A second extension set was used, but the medication still could not be flushed. An Extra dose of ceftaroline pulled from patient's med drawer and connected to other extension set, after which the medication was successfully flushed. There was patient involvement; however, no patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899756 ↗
• DeathFeb 4, 2026Air/Gas in Device

  THE EVENT INVOLVED A 60" SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK. THE REPORTER STATED THAT AN AIR POCKET WAS VISUALIZED IN THE LIPID INFUSION LINE NEAR THE CONNECTION SITE DURING PATIENT USE, RAISING CONCERN FOR A POSSIBLE AIR EMBOLISM. HEAD ULTRASOUND REVEALED PNEUMOCEPHALUS, AND TELEMETRY REVIEW WAS SUSPICIOUS FOR A CORONARY EVENT. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DRESSING WAS TAKEN DOWN AND THE ENTIRE LINE SETUP WAS CHANGED AND PRESERVED. NOTABLY, A CAP AND LINE CHANGE HAD BEEN PERFORMED APPROXIMATELY 50 MINUTES PRIOR TO THE ARREST. THE PATIENT PASSED AWAY AFTER THE EVENT. IT WAS UNCLEAR IF ANY INTERVENTIONS WERE DUE TO THE EVENT, AND THE ISSUE CURRENTLY REMAINS UNDER INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NOTE: THE SPECIFIC DATE OF DEATH IS UNKNOWN BUT IT OCCURRED ON OR AFTER (B)(6) 2026.

  Patient problems: Air Embolism; Cardiac Arrest; Pneumocephalus

  MAUDE report 24257740 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK WHERE THE CUSTOMER REPORTED THAT MICRO TUBING OR MED TUBING WAS FOUND TO HAVE A LEAK WHILE SETTING UP LINES. THE DEVICE WAS BEING USED FOR PATIENT CARE. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040626 ↗

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-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-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-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-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• 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-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• 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.