ICU Medical AM6127Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709086357), received between Jul 18, 2025 and Apr 23, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 11" (28 CM) SMALLBORE EXT SET W/NANOCLAVE¿, 6-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE REGISTERED NURSE (RN) NOTICED THAT THE MANIFOLD CONNECTED TO THE PATIENT WAS LEAKING. THE RN THEN REORDERED ALL NEW DRIPS AND REPLACED THE MANIFOLD AND THE GGT LINES CONNECTED TO IT. THE MANIFOLD WAS LEAKING AT THE LAST PORT ON THE BACK WHERE THERE WAS NO BONDED MICROCLAVE, AND THE CARRIER SOLUTION WAS INFUSING THROUGH THIS PORT. THE PATIENT WEIGHED 2.6KG. THE MEDICATION INFUSING WAS SODIUM CHLORIDE 0.45% WITH HEPARIN 1 UNIT/ML, RATE 2ML/HR AND THE MEDICATION IS INFUSED BY CENTRAL LINE, THE EVENT OCCURRED DURING PATIENT INFUSION, BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24970049 ↗
• InjuryMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA EMAIL THAT AN 11" SMALLBORE EXT SET W/NANOCLAVE®, 6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE PATIENT WAS REPORTED TO HAVE DESATURATED AT 0600 HOURS, REQUIRING SEVERAL INCREASES OF PHENYLEPHRINE, FLUID BOLUSES, AND ADDITIONAL SEDATIONS AS NEEDED. THE REGISTERED NURSE (RN) IDENTIFIED LEAKING AT THE MANIFOLD DURING A SAFETY CHECK AND EMERGENTLY ORDERED NEW DRIPS AT 0700 HOURS AND RE-COCKTAILED MEDICATIONS. NEW DRIPS WERE STARTED AT 1000 HOUR AND WITHIN AN HOUR, MEDICATIONS WERE ABLE TO BE WEANED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24678711 ↗
• MalfunctionJul 31, 2025Break; Crack; Break; Crack

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 11" (28 CM) SMALLBORE EXT SET W/NANOCLAVE®, 6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED "SUB MANIFOLD BREAKING". THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679378 ↗
• MalfunctionJul 18, 2025Fracture; Fracture

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 11 IN(28CM)APPX 0.97ML,SMALLBORE SET,NANOCLAVE,6-PORT NANOCLAVE MANIFOLD,BCV. THE CLAVE REPORTEDLY SNAPPED OFF THE MANIFOLD AND TWISTED OFF AT THE DISTAL END WITH NO MANIPULATION OR BENDING, ETC. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546902 ↗

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-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-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-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• Z-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• 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-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
• Z-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• Z-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(

…and 173 more.