ProGen PRP Advantage PROGEN-A15Recalls & reported problems
Bimini Technologies LLC · 15ML Platelet Rich Plasma production device. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850034511566), received between Sep 27, 2022 and Dec 17, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Off-Label Use” (3 reports).
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
- Off-Label Use3
- Use of Device Problem1
Patient problems
- Swelling/ Edema4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2023Off-Label Use; Off-Label Use
PATIENT ADVERSE REACTION: SWELLING AND REDNESS ON SCALP AND FOREHEAD, SWELLING OF EYE AREA, RASH AND REDNESS ON LEGS.
Patient problems: Swelling/ Edema
MAUDE report 18342384 ↗InjuryJun 14, 2023Off-Label Use; Off-Label Use
TRANSIENT SWELLING AND REDNESS WHICH MIGRATED FROM TOP OF HEAD TO LEFT FRONT SIDE, THEN TO FOREHEAD, AND FINALLY TO EYELIDS.
Patient problems: Swelling/ Edema
MAUDE report 17132072 ↗InjuryNov 16, 2022Off-Label Use; Off-Label Use
SWELLING UNDER THE EYES 11 DAYS AFTER HAVING PLATELET RICH PLASMA OBTAINED FROM THE DEVICE INJECTED IN THAT AREA. NO CONCLUSIVE ASSOCIATION HAS BEEN ESTABLISHED.
Patient problems: Swelling/ Edema
MAUDE report 15809051 ↗InjurySep 27, 2022Use of Device Problem; Use of Device Problem
SWELLING AROUND THE EYES AFTER INJECTING PRP PRODUCED USING THE DEVICE.
Patient problems: Swelling/ Edema
MAUDE report 15491706 ↗
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- Arthrex® ABS-2016-02Arthrex, Inc. · Platelet and plasma separator for bone graft handling7 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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