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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607151011925), received between Jul 12, 2019 and Dec 4, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Backflow” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT RECEIVED A BURN ON THE NECK AFTER A LIPOSUCTION PROCEDURE FOLLOWED BY RENUVION.

  Patient problems: Burn(s); Injury; Patient Problem/Medical Problem

  MAUDE report 9411289 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBDERMAL COAGULATION WITH RENUVION WAS PERFORMED ON PATIENT'S NECK AND LOWER JAW AREA FOLLOWING SUCTION ASSISTED LIPOSUCTION. THE PATIENT HAD A BURN RESULTING IN NECROTIC TISSUE.

  Patient problems: Burn(s); Injury; Necrosis; Patient Problem/Medical Problem

  MAUDE report 8821210 ↗
• MalfunctionJul 12, 2019Backflow; Improper Flow or Infusion; Infusion or Flow Problem; Backflow; Improper Flow or Infusion; Infusion or Flow Problem

  GENERATOR WAS CONTAMINATED WITH BIOLOGICAL SUBSTANCE FROM THE HAND PIECE DURING A J-PLASMA PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8784310 ↗

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-1154-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
• Z-1156-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
• 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-1157-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
• Z-1155-2018 · Feb 8, 2018 · Terminated
  J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B