ICU Medical B33973Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709123984), received between Nov 2, 2022 and Feb 24, 2025 — classified as 4 malfunctions.

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

• MalfunctionFeb 24, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN DECEMBER 2024 AND INVOLVED A 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP (BLUE), VENTED CAP. A MEDSUN MEDWATCH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED ON 27-JAN-2025 THAT STATED THE PATIENT WAS RECEIVING IV GANCYCLOVIR. A 5% DEXTROSE IV FLUSH BAG WAS ATTACHED TO A 4 PORT MANIFOLD AND THE IV GANCYCLOVIR WAS PIGGYBACKED. ONE OF THE CLAVES FROM THE MANIFOLD CAME OFF AND THE IV MEDICATION LEAKED OUT OF THE LUMEN OF THE MANIFOLD. THE MEDICATION DID NOT REACH THE PATIENT, HOWEVER THE STAFF AND TRANSPORT RN CAME IN CONTACT WITH THE HAZARDOUS MEDICATION. THIS IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. APPROXIMATE AGE OF DEVICE IS 1 DAY. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448207 ↗
• MalfunctionDec 30, 2024Break; Disconnection; Separation Problem; Break; Disconnection; Separation Problem

  IT WAS REPORTED THAT THE 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP (BLUE), VENTED CAP HAD A DISCONNECTION ISSUE. IT WAS STATED THAT THE ITEM BROKE/DISCONNECTED WHERE IT SHOULD HAVE BEEN FUSED. UNSPECIFIED MEDICATION SPLASHED ONTO A NURSE AND THE ONTO THE FLOOR. THIS IS THE SAME AREA WHERE OTHER MANIFOLDS HAVE FAILED IN THE PAST. THE MEDICATION INVOLVED WAS MYCOPHENOLATE. THERE WAS PATIENT INVOLVEMENT AND RN WAS SPRAYED WITH HAZARDOUS DRUG. THE HAZARDOUS DRUG HAS NO EFFECT TO THE RN AND THE PATIENT. THERE WERE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035656 ↗
• MalfunctionApr 2, 2024Disconnection; Separation Problem; Disconnection; Separation Problem

  THE EVENT INVOLVED A 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP (BLUE), VENTED CAP WHERE THE CUSTOMER REPORTED THAT THEY HAD A DEFECTIVE TUBING SET THAT DISCONNECTS OR SEPARATES. 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 19029477 ↗
• MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP (BLUE), VENTED CAPWHICH WAS REPORTED TO HAVE LEAKED DURING CHEMOTHERAPY INFUSION ON A PATIENT. THE REPORTER STATED THAT ONE OF THE CONNECTORS JUST POPS UP, LOOSE AND WAS NOT CONNECTING AND A LEAK WAS NOTED. IT WAS NOT REPORTED WHETHER OR NOT THERE WAS UNPROTECTED EXPOSURE TO THE CHEMOTHERAPY. NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714558 ↗

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-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-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-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
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• 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-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-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I
• 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

…and 173 more.