Plum Duo Infusion System 1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M335400021), received between Dec 5, 2024 and Oct 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K223607); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED, VIA EMAIL, THAT A PLUM DUO, ALLEGING THAT AFTER THEY PROGRAMMED A BOLUS AMOUNT, THE PUMP CONTINUED TO BOLUS AT THE BOLUS RATE. THEY WERE TOLD THAT OUR DRUG LIBRARY DID NOT INCLUDE SPECIFICS ABOUT WHAT THE PUMP SHOULD DO WHEN THE BOLUS INFUSION WAS COMPLETED, SO IT CONTINUES AT THAT RATE. THEY SET UP A CHANGE TO THE LIBRARY TO FIX THIS FOR OBSTETRIC (OB) RELATED DRUGS, BUT THE UPDATE COULD NOT BE PUSHED OUT DUE TO SERVER ISSUES WITH ICU MEDICAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407629 ↗
• MalfunctionDec 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE EVENT INVOLVED A PLUM DUO INFUSION SYSTEM WHERE IT WAS REPORTED THAT THE DEVICE SERIAL NUMBER SHOW ON SCREEN DOES NOT MATCH SERIAL NUMBER ON BARCODE LABEL DURING IMPLEMENTATION/CONFIGURATION OF DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860692 ↗
• MalfunctionDec 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE EVENT INVOLVED A PLUM DUO INFUSION SYSTEM WHERE IT WAS REPORTED THAT THE DEVICE SERIAL NUMBER SHOW ON SCREEN DOES NOT MATCH SERIAL NUMBER ON BARCODE LABEL DURING IMPLEMENTATION/CONFIGURATION OF DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223607. One submission often covers many models, so check the product and lot details in each record.

• Z-2723-2026 · Jun 10, 2026 · Open, Classified
  ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
• Z-2312-2026 · Apr 29, 2026 · Open, Classified
  Plum Duo Infusion Pump, 40002-0401
• Z-1118-2026 · Dec 15, 2025 · Open, Classified
  ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
• Z-1094-2026 · Dec 15, 2025 · Open, Classified
  Plum Duo Infusion System, List Number 40002-04-01
• Z-2129-2025 · Jul 11, 2025 · Open, Classified
  Plum Duo Infusion System, List Number: 400020401
• Z-1990-2025 · Apr 22, 2025 · Open, Classified
  ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump