ICU Medical AM6100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709070660), received between Aug 16, 2023 and Sep 12, 2025 — 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.

• MalfunctionSep 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE WITH REGARDING A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER WHERE THEY STATED THAT "THERE IS CRACKING AND CAUSING IT TO LEAK IN SEPTUM OF MANIFOLD.". THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043390 ↗
• MalfunctionSep 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE REGARDING A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT "THERE IS CRACKING AND CAUSING IT TO LEAK AT THE CONNECTION BETWEEN MANIFOLD AND EXTENSION SET." THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043379 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER WHERE IT REPORTED THAT THE MANIFOLDS ARE LEAKING AT SEVERAL ACCESS POINTS. THE EVENT OCCURRED AT 7:30 AM DURING USE ON A PATIENT, BUT UNKNOWN HOW LONG IT WAS IN USE. THE PATIENT HAD TOTAL PARENTERAL NUTRITION (TPN), DEXAMETHASONE, AND MILRINONE RUNNING AT THE TIME OF THE EVENT WHICH MADE THEM TAKE DOWN THE LINES AND GET NEW TUBING AND NEW MEDICATIONS. ADDITIONALLY, ONE END OF THE CONNECTION PIECES (THE END THAT WOULD BE CONNECTED TO OUR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)) WAS NOT LOCKING IT JUST KEPT SPINNING. THE LINE WAS IN, BUT THE PIECE OF THE PRODUCT WOULD JUST SPIN AS IF IT YOU OVER TIGHTEN A SCREW, AND IT JUST SPINS. THERE WAS PATIENT INVOLVEMENT BUT NO HARM OR ADVERSE EVENT REPORTED AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736852 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE SET LEAKED AT ROTATING LUER ON END OF SMALLBORE TUBING. THE EVENT OCCURRED DURING USE ON PATIENT, THE NURSE WENT TO CHECK THE PATIENT AND FOUND THE LEAK. THERE WAS PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729997 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER. IT WAS STATED IN THE REPORT THAT THE PRODUCT IS LEAKING AT THE ROTATING LUER CONNECTION ON SMALLBORE TUBING. THE EVENT OCCURRED ON (B)(6) 2023 AT 5:30 AM DURING USE ON A PATIENT, BUT UNKNOWN HOW LONG IT WAS IN USE. ADDITIONALLY, THE PRODUCT IS AVAILABLE FOR EVALUATION AND A MEDICATION WAS BEING USED WITH THIS PRODUCT. THERE WAS PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED AND NO DELAY IN THERAPY. TOTAL PARENTERAL NUTRITION, MORPHINE, DEXMEDETOMIDINE, AND VERSED WERE INFUSING AT THE TIME THE LEAK WAS FOUND. THERE WAS NO OBVIOUS DEFECT OR CRACK NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728130 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER. IT WAS STATED IN THE REPORT THAT THE PRODUCT WAS LEAKING WHERE THE EXTENSION TUBING IS FUSED TO THE MANIFOLD. A MEDICATION WAS BEING USED WITH THIS PRODUCT. THERE WAS PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712091 ↗
• MalfunctionAug 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE, CLAMP, ROTATING LUER, WHERE IT WAS REPORTED THAT THE NANOCLAVE MANIFOLD LEAKED NEAR THE BASE OF THE 2 NANOCLAVES NEAREST TO EXTENSION TUBING. THE CUSTOMER DISCOVERED THE WET AREA ON THE PATIENT IN CVICU DURING INFUSION. THE MEDICATION INVOLVED IS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, NO HARM/ADVERSE EVENT, AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556990 ↗

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-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-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• 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-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(
• Z-0217-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)
• Z-0260-2021 · Jul 6, 2020 · Terminated
  124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• 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

…and 173 more.