Revolve ENVI 600 Advanced Adipose System RV0001E600Recalls & reported problems
Lifecell Corporation · Tissue Processing System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818410012410), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2023Leak/Splash; Leak/Splash
HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE REQUESTING A "CREDIT FOR A DEFECTIVE REVOLVE® SYSTEM." THE STATUS OF THE DEVICE IS UNKNOWN. HEALTHCARE PROFESSIONAL SUBSEQUENTLY REPORTED "FELT AS THOUGHT THE MESH HAD A HOLE OR THE MESH WAS NOT ON CORRECTLY AND HIS FAT WAS BEING SUCKED OUT OF THE BOTTOM. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "THE ISSUE WAS NOTED DURING THE RINSING STAGE, WHEN FAT WAS NOTED IN THE WASTE CONTAINER AND NOT TRAPPED IN THE REVOLVE SYSTEM FOR PATIENT USE. APPROXIMATELY 400CC OF FAT WAS WASTED." "THE PATIENT DID NOT RECEIVE THE FULL BENEFIT OF THE PROCEDURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18328389 ↗
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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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