ICU Medical AM6128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709086968), received between Dec 10, 2023 and Nov 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING SMALLBORE EXTENSION SET W/ 6-PORT NANOCLAVE MANIFOLD WHERE IT WAS REPORTED THAT THE PATIENT WAS ON MEDICATIONS. RN WAS CHECKING THE PATIENT WHEN SHE FELT THE MATTRESS WAS WET. RN PICKED UP THE MANIFOLD, AND ONE OF THE PORTS CRACKED OFF COMPLETELY. PATIENT'S BLOOD PRESSURE AND HEART RATE HAD DROPPED SIGNIFICANTLY, AND THEY HAD TO PUSH EMERGENCY MEDICATIONS. PATIENT IS CURRENTLY STABLE AGAIN. THE PRODUCT WAS USED ROUGHLY 4-8 HOURS. THERE WAS PATIENT HARM AND THERE WAS DELAY IN THERAPY.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23632933 ↗
• MalfunctionDec 10, 2023Disconnection; Disconnection

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE IN THE PEDIATRIC INTENSIVE CARE UNIT AND INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW, GREEN RINGS), NANOCLAVE® (LIGHT BLUE RING), CHECK VALVE, CLAMP, ROTATING LUER. THE NURSE NOTICED THAT THE SPIN COLLAR OF THE MANIFOLD HAD MOVED OFF OF THE CONNECTING MICROCLAVE ON ITEM #MC33213 AND SLIPPED DOWN THE EXTENSION TUBING OF THE MANIFOLD. WHEN SHE TRIED TO RECONNECT IT, IT WOULD NOT CONNECT. IT WAS REPORTED THAT THE SPIN COLLAR THREADING MAY HAVE BEEN STRIPPED OR DAMAGED. IT IS UNKNOWN IF A PATIENT WAS INVOLVED IN THE EVENT, HOWEVER, THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298453 ↗

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-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-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-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-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
• 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-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-0262-2021 · Jul 6, 2020 · Terminated
  8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron i
• Z-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
• 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-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.