Volumat™ Line VL PR 72-11Recalls & reported problems
Fresenius Kabi AG · Class 2
All models of Volumat Line (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250273714333), received between Feb 9, 2026 and Feb 9, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K121613, K220301); 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Infusion or Flow Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: A REGISTERED NURSE REPORTED THAT A KABI VMC AGILIA PRIM FILTER HAD A SALINE-FILLED CHAMBER BUT WOULD NOT BYPASS THE CHAMBER INTO THE LINE. ONE BAG OF SALINE WAS DISCARDED WITH THE SET. NO ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293093 ↗MalfunctionFeb 9, 2026Infusion or Flow Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: A REGISTERED NURSE REPORTED THAT A KABI VMC AGILIA PRIM FILTER HAD A SALINE-FILLED CHAMBER BUT WOULD NOT BYPASS THE CHAMBER INTO THE LINE. ONE BAG OF SALINE WAS DISCARDED WITH THE SET. NO ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293092 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121613, K220301. One submission often covers many models, so check the product and lot details in each record.
- Z-2064-2019 · Jun 24, 2019 · TerminatedVOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to
- Z-0362-2019 · Dec 2, 2017 · TerminatedVolumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to
Other Pump, Infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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