ICU Medical MC330715Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709127197), received between Dec 31, 2024 and Oct 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK WHERE A LEAK DURING PATIENT USE WAS REPORTED. THE CUSTOMER CHANGED THE TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS ON PM SHIFT. ALL HAPPENED WITHIN 1-2HRS OF HANGING THE NEW BAGS. NO PATIENT WAS HARMED, BUT IT ADDED TIME AND ADDITIONAL RESOURCES TO CHANGE THE TUBING AGAIN AND HAVING TO CHANGE THE LINEN. THE LEAKING OCCURRED AT THE ACTUAL FILTER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293266 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOC. IT WAS REPORTED THAT THE FILTER SET 9" HAS LEAKING AT THE FILTER. FILTER WAS ON UNDER 12 HOURS OF USE WHEN LEAKING OCCURRED. SOMEONE BECAME AWARE OF THE ISSUE WHEN LIQUID WAS FOUND ON THE FILTER AND ON THE BED. THE CUSTOMER STATED THAT THE PRODUCTS HAVE TRIFUSE ATTACHED, AND THE CONNECTION AT THE MICROCLAVE WAS LEAKING BEHIND THE MICROCLAVE ON WHERE THE TUBING IS BONDED WITH GLUE TO THE CONNECTOR. THERE WAS NO MEDICATION BEING USED WITH THE PRODUCT BUT TPN WAS USED WITH THE FILTER AT TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT, THERE WAS DELAY IN THERAPY, NO ADVERSE EVENT, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049227 ↗

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-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-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-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• Z-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887
• 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-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-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-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.

…and 173 more.