ICU Medical MC33315Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709037694), received between May 20, 2025 and Sep 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941154 ↗
• MalfunctionSep 28, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923990 ↗
• MalfunctionMay 20, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER. THE CUSTOMER REPORTED THAT THEY HAD AN UPTICK OF INCIDENTS WITH THE BIFUSE AND TRIFUSE DEVICES, IN GENERAL. FOR THIS SPECIFIC REPORTED EVENT, THE PATIENT REQUIRED TWO CHEMOTHERAPIES CONTINUOUSLY RUNNING. THE NURSE PLACED THE BIFUSE DEVICE TO THE PATIENT LINE AND ATTACHED CHEMOTHERAPY WITH AN UNSPECIFIED CLOSED TRANSFER SYSTEM DEVICE (CTSD). THE BIFUSE CAME OFF AND A SMALL AMOUNT OF CHEMO LEAKED ONTO FLOOR. THE NURSE THEN ATTACHED THE BIFUSE TO THE CSTD PIECE AND RESTARTED THE CHEMO. THE BIFUSE CAME OFF OF THE CSTD AND SMALL AMOUNT OF CHEMO AGAIN LEAKED ONTO FLOOR. THE NURSE NOTED THAT WHEN THE BIFUSE WAS ATTACHED TO CSTD, IT WAS ABLE TO BE PULLED OFF OF THE CSTD WITH ONLY A SMALL AMOUNT OF PULLING, DUE TO THE SMALLER COLLAR ON BIFUSE. ALTHOUGH THE PRODUCT COULD HAVE COME IN CONTACT WITH THE PATIENT AND/OR STAFF MEMBER, YET THE MEDICATION BEING ADMINISTERED, DID NOT GET ON PATIENT OR STAFF SKIN OR CLOTHING. THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL. THUS, THERE WAS NO STAFF OR PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057374 ↗
• MalfunctionMay 20, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER. THE CUSTOMER REPORTED THAT THEY HAD AN UPTICK OF INCIDENTS WITH THE BIFUSE DEVICE, IN GENERAL. FOR THIS SPECIFIC REPORTED EVENT, THE PATIENT WAS CONNECTED TO A CENTRAL VENOUS LINE (CVL) WITH IV FLUIDS (IVF) USING A SYRINGE (MEDLINE) ON THE BIFUSE. THE NURSE WAS CALLED TO ROOM FOR A TUBING BREAK AT THE BIFUSE CONNECTION. THE PATIENT DID NOT DO ANYTHING SPECIFIC PER MOM (MEDICAL MOM) FOR TUBING TO HAVE BROKEN LIKE IT DID. IT WAS ALSO STATED THAT UNSPECIFIED CHEMO WAS HOOKED UP TO THE CONNECTOR AND NO CHEMO WAS LOST. ALTHOUGH THE PRODUCT COULD HAVE COME IN CONTACT WITH THE PATIENT AND/OR STAFF MEMBER, YET THE MEDICATION BEING ADMINISTERED, DID NOT GET ON PATIENT OR STAFF SKIN OR CLOTHING. THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL. THUS, THERE WAS NO STAFF OR PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057066 ↗

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-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-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0237-2021 · Jul 6, 2020 · Terminated
  20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(1
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01
• Z-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2
• 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-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.

…and 173 more.