ICU Medical AM6152Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709122420), received between Jul 24, 2024 and Aug 7, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173748 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165737 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak

  THE INCIDENT WAS REPORTED BY (B)(6) HOSPITAL. THE EVENT INVOLVED 20 INCH (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W CLAVE CLEAR, 2 6-PORT NANOCLAVE MANIFOLDS, 2 CHECK VALVES, SPIN LUER WITH LIST NUMBER AM6152 AND LOT NUMBER UNKNOWN: IT WAS REPORTED THAT THE PATIENT TRANSFERRED FROM OUTSIDE HOSPITAL AND PLACED ON ALL OF THEIR HOSPITAL DRIPS AND DRIPS COCKTAILED THROUGH 12 PORT MANIFOLD. PRODUCT NOTED TO BE LEAKING IN BED BY NIGHT SHIFT REGISTERED NURSE. PATIENT SINCE TRANSFERRED WAS HAVING ISSUES WITH BLOOD PRESSURE AND ORIGINALLY WAS THOUGHT TO BE A CENTRAL LINE ISSUE BUT SINCE PRODUCT WAS CHANGED PATIENT HAS NOT HAD ANY VITAL ISSUES. REGISTERED NURSE REPORTED LEAK TO OCCUR AT BONDED PORT ATTACHING THE TUBING CLOSEST TO THE PATIENT TO THE PORTED MICROCLAVES. THIS EXACT LOCATION FOR LEAKING HAS BEEN A RECURRENT THEME AND MUST BE ESCALATED DUE TO THE SEVERITY OF IMPACT AND RISK CAUSED TO PATIENT. INCREASED RISK FOR CLABSI DUET TO OPEN SYSTEM IN CENTRAL LINE. PATIENT HEMODYNAMICALLY UNSTABLE SINCE ADMISSION AND PLANNED OR ON (B)(6) 2026. THE MEDICATION ADMINISTRATION TO PATIENT GOT DELAYED. THE FOLLOWING MEDICATIONS LIKE PRECEDEX, EPINEPHRINE, DILAUDID, VASOPRESSIN, CARRIER SOLUTION WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25463087 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿ MANIFOLDS, 2 CHECK VALVES, SPIN LUER WITH ITEM NUMBER AM6152 AND POSSIBLE LOT NUMBERS 14602672, 14769303, 14805220: IT WAS REPORTED THAT THE REGISTERED NURSE AND THE PATIENT'S MOTHER NOTICED THAT PATIENT'S SHEETS AND BLANKET WERE WET, SUBSEQUENTLY NOTICED THAT THE MANIFOLD OF THE GTT LINE WAS LEAKING AND NOT ABLE TO BE SCREWED ON TIGHTER. THE REGISTERED NOTIFIED FRONT LINE PROVIDER AND COCKTAILED NEW DRIPS IN A SEPTAFUSE INSTEAD OF THE MANIFOLD AND REPLACED LEAKING MANIFOLD. THIS WAS THIRD EVENT WHERE LEAKING WAS OBSERVED IN THE SAME SPOT WITHIN ONE WEEK. AS PER THE HOSPITAL'S POLICY, THEY CANNOT RETURN SAMPLES THAT HAVE BEEN USED WITH A PATIENT, SO CUSTOMER RETURNED 3 UNOPENED SAMPLES. THIS EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460687 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿ MANIFOLDS, 2 CHECK VALVES, SPIN LUER WHERE THE CUSTOMER REPORTED THAT THE PATIENT MANIFOLD FOUND TO BE LEAKING AT THE CONNECTION SITE BETWEEN THE PORTS. NEW GTTS LINES ORDERED & PRIMED AND THE MANIFOLD WAS CHANGED. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903258 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED THE FOLLOWING DEVICE: 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿ MANIFOLDS, 2 CHECK VALVES, SPIN LUER. THE MANIFOLD WAS REPORTEDLY LEAKING SIGNIFICANTLY AN UNSPECIFIED FLUID/INFUSATE OUT OF DRIP LINE ONTO THE BED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751859 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿ MANIFOLDS, 2 CHECK VALVES, SPIN LUER GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THE LEAK WAS IN THE TUBING BETWEEN THE TWO SETS OF MANIFOLDS. THE SAMPLE IMPACTED WAS DISCARDED AND NOT AVAILABLE FOR RETURN. THERE WAS A PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822581 ↗

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-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-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-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-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• 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-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01

…and 173 more.