ICU Medical AC315Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709121379), received between Nov 28, 2023 and Jul 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Disconnection

  THE EVENT INVOLVED A 12 IN (30 CM) APPX 1.6 ML, EXT SET W AND 3-GANG NANOCLAVE STOPCOCK W AND NANOCLAVE, SPIN LUER: IT WAS REPORTED THAT NANOCLAVE BROKE AND MANIFOLD BECAME DISCONNECTED FROM PATIENT. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747543 ↗
• MalfunctionMar 6, 2026Disconnection

  AN EVENT INVOLVED A 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE STOPCOCK W/NANOCLAVE, SPIN LUER WHERE IT WAS REPORTED THAT UPON ASSESSMENT, FLUSH LINE ATTACHED TO THE DISTAL PORT OF THE MANIFOLD WAS DETACHED HANGING ON FLOOR. NO AIR IN LINE NOTED, LINE DISCONTINUED FROM PATIENT. NORMAL SALINE (NS) FLUSH RUNNING ONTO FLOOR. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529570 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SPIN LUER THAT LEAKED DURING PATIENT USE. THE REPORT STATES THAT THE MANIFOLD WAS LEAKING AT THE DISTAL PORT. THE CONNECTIONS WERE CHECKED AND WERE NOT LOOSE. NO CRACKS WERE OBSERVED ON EITHER THE MANIFOLD OR THE INTRAVENOUS (IV) TUBING SET. THE BLOOD WAS BACKFLOWING INTO THE MANIFOLD AND THE CENTRAL VENOUS CATHETER (CVC) LINE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324664 ↗
• MalfunctionFeb 2, 2026Component Missing; Air/Gas in Device

  THE RUBBER PART OF THE FOUR-WAY STOPCOCK OF THE FOLLOWING DEVICE: '12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SPIN LUER' WAS REPORTEDLY MISSING THE RUBBER PIECE OF THE POWER PORT AND AIR WAS BEING ENTRAINED. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242551 ↗
• MalfunctionNov 25, 2025Disconnection; Disconnection

  EVENT OCCURRED REGARDING 12 IN (30 CM) APPX 1.6 ML, EXT SET WHERE IT WAS STATED IN THE REPORT THAT THE PRODUCT FAILED DURING USE. THE NANOCLAVE PROXIMAL TO THE PATIENT BROKE IN SUCH A WAY THAT THE OUTER PLASTIC PIECE BECAME COMPLETELY DISCONNECTED FROM THE INNER LUMEN. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649751 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SPIN LUER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE MANIFOLD WAS LEAKING BETWEEN TWO OF THE STOPCOCKS WHERE IT IS SUPPOSED TO BE BONDED. THE MANIFOLD HAD BEEN IN PLACE FOR 5 HOURS BEFORE THE LEAKING WAS NOTICED. NO HEMOSTATS WERE USED ON THIS DEVICE. IT WAS CONFIRMED THAT THIS WAS NOT SPILLAGE THAT OCCURRED WHILE THE MANIFOLD WAS BEING SET UP. THE EVENT HAPPENED IN NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM WAS REPORTED TO BE ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221852 ↗

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-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-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-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-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887
• 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-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I

…and 173 more.