ICU Medical AM3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709088511), received between Jul 26, 2023 and Apr 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

187 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.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionApr 19, 2024Premature Activation; Premature Activation

  THE EVENT INVOLVED A 112" 15 DROP PRIMARY SET W/3 MICROCLAVE¿, 3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, ROTATING LUER WHERE IT WAS REPORTED THE VALVES IN THE MANIFOLD SEEM TO MALFUNCTION (SPECIFICALLY THE PORT PROXIMAL TO THE PATIENT). IT WAS STATED THAT THE PART THAT IS HAVING AN ISSUE IS THE THIRD PORT ON THE MANIFOLD, CLOSEST TO THE PATIENT/END OF THE SET. THE CLINICIANS PRIME THE SET, CLOSE THE ROLLER CLAMP AT THE TOP, AND THEN ATTACH THE SYRINGES TO THE MANIFOLD FOR WHEN THEY ARE READY TO ADMINISTER THE MEDICATION. THE PORT ON THE MANIFOLD CLOSEST TO THE PATIENT IS PULLING THE MEDICATION FROM THE ATTACHED SYRINGE ON ITS OWN AND INTO THE PATIENT. THIS OCCURRED AFTER THE LINES WERE PRIMED AND HOOKED UP TO THE PATIENT BUT PRIOR TO THE START OF INFUSION CAUSING THE MEDICATION TO BE DELIVERED PREMATURELY TO THE PATIENT WITHOUT A CLINICIAN ADMINISTERING IT. THERE WAS PATIENT INVOLVED, HOWEVER, NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143167 ↗
• MalfunctionJul 26, 2023Inaccurate Delivery; Inaccurate Delivery

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, ROTATING LUER. THE ANESTHESIA PROVIDER REPORTED THAT THE DEVICE HAD CHECK/REGURGITATION VALVE FAILURES PREVENTING IN-LINE PHARMACEUTICAL DELIVERY VIA SYRINGE FROM TRAVELING UPSTREAM INTO SPIKED FLUID BAGS (USUALLY CONTAINING CRYSTALLOIDS). SOME OF THE FACILITY'S MEDICATIONS ARE OPAQUE AND EASILY OBSERVED IN THE TUBING. HOWEVER, FOR MEDICATIONS THAT ARE NOT OPAQUE, IT IS IMPOSSIBLE TO DETERMINE THE DIRECTION OF TRAVEL (WHERE THERE IS LESS RESISTANCE), USUALLY TOWARD THE SPIKED FLUIDS. THIS WOULD RENDER THE INFUSION TO BE INEFFECTIVE. THE CUSTOMER REPORTED THAT IT WOULD BE EVEN WORSE IF A PATIENT RECEIVED PART OF A PHARMACEUTICAL MEDICATION AT STRENGTH, THEREFORE ONLY ACHIEVING A PARTIAL DESIRED REACTION. FOR EXAMPLE, A PATIENT COULD BECOME UNCONSCIOUS DURING THE ANESTHESIA INDUCTION, BUT NOT AT THE DEPTH NEEDED FOR SURGERY. SUBSEQUENTLY, A PARTIAL DOSE MAY PROVIDE ONLY A PORTION OF THE DESIRED EFFECT, LEAVING THE PROVIDER UNABLE TO DETERMINE TREATMENT PLAN EFFICACY. THE COMPLAINANT FURTHER INDICATED THAT SUBSEQUENT POTENTIAL CATASTROPHIC OUTCOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396919 ↗

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-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-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-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-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
• 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-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• 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-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• Z-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847

…and 172 more.