J-PLASMA® PRECISE™ BVX -150-BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607151011871), received between Jun 27, 2018 and Oct 4, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K170188); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS SCARRING ON HER ABDOMINAL AREA AFTER A LIPOSUCTION PROCEDURE FOLLOWED BY RENUVION.

  Patient problems: Patient Problem/Medical Problem; Scarring

  MAUDE report 9156381 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  REPORTED COMPLAINT FOR ACUTE RIGHT CHEST WALL HEMATOMA FOLLOWING SURGERY. BLOOD PRESSURE UPON PRESENTATION WAS 190/110. RIGHT CHEST WALL WAS EVACUATED OF A 350CC HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 8613029 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  COMPLAINT FOR A RIGHT AXILLARY SKIN ULCER. POST OP EXAM WAS NORMAL 2 DAYS AFTER SURGERY, ULCER DEVELOPED 3 DAYS AFTER POST OP EXAM. THE PROCEDURE INCLUDED LIPOSUCTION FOLLOWED BY RENUVION COSMETIC TECHNOLOGY. DEBRIDEMENT FOR THE ULCER WAS REQUIRED.

  Patient problems: Injury; Tissue Damage; Ulcer

  MAUDE report 8543341 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED COMPLAINT ALLEGE THAT THE PATIENT RECEIVED A BURN ON THE PATIENT FACE/ JAWLINE DURING A PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 7643523 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170188. One submission often covers many models, so check the product and lot details in each record.

• Z-2060-2020 · Apr 20, 2020 · Terminated
  Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for el
• Z-1157-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
• Z-1156-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
• Z-1155-2018 · Feb 8, 2018 · Terminated
  J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
• Z-1153-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
• Z-1154-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N