ICU Medical Z1120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709022409), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED SATURDAY EVENING AND INVOLVED A 7" SMALLBORE EXT SET W/MICROCLAVE®, MICROCLAVE® T-CONNECTOR, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THE INTRAVENOUS (IV) TUBING WAS LEAKING WHICH RESULTED IN BLOOD LOSS ON A NEONATE IN ICN 08. IT WAS STATED THAT THE NURSE WENT TO GIVE MEDICATIONS AT 8 PM AND SAW THAT A SMALL AMOUNT OF TOTAL PARENTAL NUTRITION (TPN) AND BLOOD MIXTURE HAD COLLECTED IN THE SMALL TRAY IN THE PATIENT'S BED. UPON FURTHER INVESTIGATION OF THE TUBING AND CONNECTIONS, THE CONNECTIONS WERE FOUND TO BE TIGHT, BUT THE FLUIDS AND BLOOD WERE LEAKING AT THE HUB. THE DEVICE WAS THEN SWITCHED OUT AND THE NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED. ABOUT AN HOUR LATER, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE NNP WAS NOTIFIED AGAIN. A BOLUS OF MEDICATION WAS THEN ADMINISTERED. THE STAFF TOOK THE GIRAFFE APART DOWN TO THE AREA NEAR THE FAN AND THEY FOUND A DECENT AMOUNT OF BLOOD AND TPN THAT HAD ACCUMULATED THERE. ALL OF THE LEAKAGE WAS NOT INITIALLY VISIBLE BECAUSE THE CONNECTION WAS TOWARDS THE BOTTOM OF THE MATTRESS AND SOME LEAKAGE WAS LATER FOUND IN BETWEEN PARTS OF THE PATIENT¿S BED. THE PATIENT REQUIRED A BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 12819243 ↗

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-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-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-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-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• 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-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090

…and 173 more.