ICU Medical 12515-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709047068), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 death.

The most frequently reported specific device problem is “Disconnection” (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.

• DeathApr 6, 2023Disconnection; Failure to Deliver; Disconnection; Failure to Deliver

  IT WAS REPORTED THAT A PATIENT EXPIRED IN THE CATH LAB DUE TO THE MICROCLAVE® CLEAR TUBING NOT BEING CONNECTED. THE FACILITY INDICATED THAT THEY USE THE PRODUCT AS THEIR PRIMARY TUBING FOR 12517-01, 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER ADDED THAT THEY ARE TRYING TO EDUCATE STAFF AND MAKE THEM AWARE THAT THIS CONNECTION IS HARD TO ATTACH AND WILL COME APART IF NOT PLACED PROPERLY. THE PATIENT WAS HAVING A CARDIAC CATHETERIZATION FOR AN ACUTE MYOCARDIAL INFARCTION. DURING THE PROCEDURE, A HEPARIN BOLUS WAS GIVEN. THE CARDIOLOGIST NOTED THROMBI BUILDING UP AROUND THE CARDIAC WIRES WHILE PERFORMING THE PROCEDURE. ACTIVATED CLOTTING TIME (ACT) LEVEL RETURNED AS NORMAL AND SHOULD HAVE READ HIGH AFTER RECEIVING THE HEPARIN. THE INTRAVENOUS (IV) SITE AND CONNECTIONS WERE CHECKED BENEATH THE STERILE DRAPES, AND IT WAS FOUND THAT THE IV TUBING HAD BECOME DISCONNECTED FROM THE IV EXTENSION TUBING. DUE TO THE PATIENT NOT RECEIVING ANY ANTICOAGULANTS, THROMBI FORMED WITHIN THE CARDIAC ARTERY, WHICH RESULTED IN A CARDIAC ARREST. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL, AND THE PATIENT DIED. UP

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 16691497 ↗

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-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-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-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• 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-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• 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-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.
• 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-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per

…and 173 more.