Revolve Advanced Adipose System RV0001Recalls & reported problems
Lifecell Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M328RV000106), received between Jan 22, 2025 and Jan 28, 2025 — classified as 3 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Inflammation3
- Post Operative Wound Infection3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE THAT THEY HAVE "DONE 10 FAT GRAFTING CASES WITH REVOLVE [AT THE HOSPITAL]. 3 OF THEM AT ABOUT THE 2 WEEK POST OP MARK, HAVE PRESENTED WITH INFLAMMATION AND NEEDED IV ANTIBIOTICS. NO FLUID, JUST INFLAMMATION WITH REDNESS." THIS IS CASE 3 OUT OF 3. THE DEVICE LOT INFORMATION AND RETURN STATUS ARE UNKNOWN.
Patient problems: Inflammation; Post Operative Wound Infection
MAUDE report 21254178 ↗InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE THAT THEY HAVE "DONE 10 FAT GRAFTING CASES WITH REVOLVE [AT THE HOSPITAL.] 3 OF THEM AT ABOUT THE 2 WEEK POST OP MARK, HAVE PRESENTED WITH INFLAMMATION AND NEEDED IV ANTIBIOTICS. NO FLUID, JUST INFLAMMATION WITH REDNESS." THIS IS CASE 2 OF 3. THE DEVICE LOT INFORMATION AND RETURN STATUS ARE UNKNOWN.
Patient problems: Inflammation; Post Operative Wound Infection
MAUDE report 21245784 ↗InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE THAT THEY HAVE "DONE 10 FAT GRAFTING CASES WITH REVOLVE [AT THE HOSPITAL.] 3 OF THEM AT ABOUT THE 2 WEEK POST OP MARK, HAVE PRESENTED WITH INFLAMMATION AND NEEDED IV ANTIBIOTICS. NO FLUID, JUST INFLAMMATION WITH REDNESS. ONE OF THE PATIENTS HAD AN ELEVATED WHITE BLOOD COUNT." THIS IS CASE 1 OF 3. THE DEVICE LOT INFORMATION AND RETURN STATUS ARE UNKNOWN.
Patient problems: Inflammation; Post Operative Wound Infection
MAUDE report 21209022 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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