ICU Medical MC330690Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709124004), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT INVOLVED AN ADMIN SET, CLAVE¿, EXT SMALLBORE, 2 NANOCLAVE¿ , EXPERIENCED SEPARATION AND LEAKAGE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿ MATERIOVIGILANCE INCIDENT ON JULY 5TH AND ON JULY 8TH WITH THE TUBING". A PHOTO OF THE DEVICE WAS PROVIDED, THE PHOTO IS SHOWING A TUBING CONNECTED TO A 150ML ULTRAVIST 370 ( 370 MG IODINE/ML ) SOLUTION FOR INJECTION/INFUSION IOPROMIDE . UPDATE FROM INITIAL REPORTER: ¿TUBING BROKE OFF, THE DEVICE WAS NOT RETAINED BUT A PHOTO WAS PROVIDED. THE TUBING WAS USED TO INJECT FDG, TO PERFORM THE IMAGINING, A PART OF THE TUBING WAS REMOVED, THE SYRINGE WAS CONNECTED AND THE EXTENSION TO INJECT THE CONTRAST PRODUCT . THE TUBING BROKE OFF AT THE FIRST 3CM DURING THE ADMINISTRATION OF THE CONTRAST PRODUCT AT TEP 2, BLUE CATHETER VELOCITY OF 1.8 ML/S. CONSEQUENCES: NO CONTRAST PRODUCT WAS INJECTED TO THE PATIENT, BLOOD REFLUX WITH THE CONTAMINATION OF THE PET SCAN AND THE FLOOR WITH BLOOD.¿ THE CUSTOMER ALSO STATED THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT, THE INCIDENT OCCURRED DURING USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956833 ↗

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-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-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• Z-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510
• Z-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
• Z-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p

…and 173 more.