ICU Medical MC330479Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709090200), received between Jul 14, 2023 and Sep 23, 2026 — classified as 5 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fluid/Blood Leak

  The event involved a 7" (18 cm) Appx 0.62 ml, Smallbore Quadfuse Ext Set with 4 MicroClave Clear, 4 Clamps, Luer Lock reported that when the staff from customer facility was preparing and flushing quadfuse for use, one line was unable to flush. Upon removing the syringe, it was found that the clave was broken and did not recoil back into position. Upon opening package, no defect was observed. Registered nurse began priming the 4 lines with saline and noticed the clave was broken when removing the flush from that specific clave prior to patient use. The quadfuse was not used on a patient. Only saline had been flushed through the quadfuse and was not used on a patient. There was no patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871523 ↗
• MalfunctionFeb 27, 2026Material Separation

  AN EVENT INVOLVING SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE CLEAR CLAMPS REPORTED THAT THE BIFUSE WERE BREAKING OFF AT THE CONNECTION SITE TO THE PATIENT OCCURRED IN PATIENT USE WITH MEDICATION CONTINUOUS INFUSIONS. THERE WAS PATIENT INVOLVEMENT, THERE WAS DELAY IN SEDATION AND LINE WAS OCCLUDED AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: Hematoma

  MAUDE report 24468473 ↗
• MalfunctionDec 22, 2023Break; Break

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLAMPS, LUER LOCK THAT WAS REPORTED TO BE BROKEN AT THE QUAD SITE. AT THE TIME THERE WAS ONLY NORMAL SALINE IN THE LINE. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVED IN THE EVENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385406 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE EVEN OCCURRED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLAMPS, LUER LOCK. THE CUSTOMER REPORTED THAT THE DEVICE LOOKS NORMAL BUT WHEN ATTACHED TO THE OTHER LINES, IT BECOMES DETACHED FROM THE NEW LINES AND THE MIDDLE PART OF THE MICROCLAVE REMAINS INDENTED IN THE PRODUCT. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038761 ↗
• MalfunctionJul 14, 2023No Flow; Physical Resistance/Sticking; No Flow; Physical Resistance/Sticking

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLAMPS, LUER LOCK, WHERE IT WAS REPORTED THE NANOCLAVE REMAIN DEPRESSED WHEN TRYING TO COMPLETE TOTAL PARENTERAL NUTRITION (TPN) INFUSION PROCEDURE AND ¿POPPED¿ CAUSING AN OCCLUSION ALARM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325379 ↗

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-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-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-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-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.
• 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-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• 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-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-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30

…and 173 more.