ICU Medical Z0792Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709021822), received between Sep 14, 2023 and Nov 1, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Flow” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023No Flow; No Flow

  THE CUSTOMER RETURNED 4 USED DEVICES FOR INVESTIGATION. FLUID FLOW OCCLUSIONS WERE CONFIRMED IN ALL FOUR OF THE RETURNED USED Z0792 EXTENSION SET ASSEMBLIES, HOWEVER, NO LEAKAGE WAS OBSERVED. THIS CAPTURES 2 OF 4 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050713 ↗
• MalfunctionNov 1, 2023No Flow; No Flow

  THE CUSTOMER RETURNED 4 USED DEVICES FOR INVESTIGATION. FLUID FLOW OCCLUSIONS WERE CONFIRMED IN ALL FOUR OF THE RETURNED USED Z0792 EXTENSION SET ASSEMBLIES, HOWEVER, NO LEAKAGE WAS OBSERVED. THIS CAPTURES 3 OF 4 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050488 ↗
• MalfunctionNov 1, 2023No Flow; No Flow

  THE CUSTOMER RETURNED 4 USED DEVICES FOR INVESTIGATION. FLUID FLOW OCCLUSIONS WERE CONFIRMED IN ALL FOUR OF THE RETURNED USED Z0792 EXTENSION SET ASSEMBLIES, HOWEVER, NO LEAKAGE WAS OBSERVED. THIS CAPTURES 4 OF 4 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050232 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE FILTER HAD OCCLUSION ISSUES OR LEAKING. ICU MED-PORTFOLIO SALES SPECIALIST CONFIRMED THAT THEY ARE USING THEM WITHIN THE MANUFACTURER'S RECOMMENDATIONS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775617 ↗
• MalfunctionSep 14, 2023No Flow; No Flow

  THE INCIDENT INVOLVED A 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE CUSTOMER HAD A REPORT OF A TOTAL PARENTERAL NUTRITION (TPN) FILTER OCCLUSION IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM. THIS IS THE THIRD OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744221 ↗
• MalfunctionSep 14, 2023No Flow; No Flow

  THE INCIDENT INVOLVED A 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE CUSTOMER HAD A REPORT OF A TOTAL PARENTERAL NUTRITION (TPN) FILTER OCCLUSION IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM. THIS IS THE SECOND OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744219 ↗
• MalfunctionSep 14, 2023No Flow; No Flow

  THE INCIDENT INVOLVED A 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE CUSTOMER HAD A REPORT OF A TOTAL PARENTERAL NUTRITION (TPN) FILTER OCCLUSION IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM. THIS IS THE FIRST OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744215 ↗

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-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-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-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-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1
• 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
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• 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-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0238-2021 · Jul 6, 2020 · Terminated
  11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1
• Z-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav

…and 173 more.