J-PLASMA® PRECISE™ BVX-330BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607151010157), received between Jul 3, 2018 and Jan 28, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K151325); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IN (B)(6), THE PATIENT PRESENTED WITH SEVERAL BURNS OF VARIOUS SIZES ON THE RIGHT FLANK THAT FIRST APPEARED 3 WEEKS AFTER THE SURGICAL PROCEDURE. THE INVESTIGATION CONCLUDED THAT THE REPORTED ISSUE IS ASSOCIATED WITH POOR SURGICAL TECHNIQUE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 11242774 ↗
• InjuryDec 4, 2020Use of Device Problem; Use of Device Problem

  IN (B)(6), DURING A COSMETIC PROCEDURE, AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS NOT RECOGNIZED BY THE USER AND RESULTED IN AN ADDITIONAL MEDICAL INTERVENTION TO REMOVE THE FRAGMENT FROM THE PATIENT. THE PATIENT RECOVERED WITH NO COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10945649 ↗
• MalfunctionApr 23, 2020Use of Device Problem; Use of Device Problem

  DURING CLINICAL USE, AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS RECOGNIZED BY THE USER AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS NO INJURY TO THE PATIENT OR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989962 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A PROCEDURE PERFORMED TO TREAT LOCALIZED ADIPOSITY AND EXTREME LAXITY OF THE NECK AND LOWER FACE THAT INCLUDED VIBRATION ASSISTED LIPOSUCTION FOLLOWED BY RENUVION. THERE WERE NO COMPLICATIONS IMMEDIATELY FOLLOWING THE PROCEDURE. ON A POST-OPERATIVE FOLLOW UP 4 MONTHS LATER, THE PATIENT PRESENTED WITH SUBDERMAL BUNCHING IN THE NECK AREA.

  Patient problems: Adhesion(s); Patient Problem/Medical Problem

  MAUDE report 9949488 ↗
• MalfunctionJul 3, 2018Device Operational Issue; Device Operational Issue

  COMPLAINTS ALLEGED THAT DURING LAPAROSCOPIC ABLATION PROCEDURE THE J-PLASMA HANDPIECE WAS NOT WORKING PROPERLY. NO PATIENT INJURY RESULTED FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151325. One submission often covers many models, so check the product and lot details in each record.

• Z-2061-2020 · Apr 20, 2020 · Terminated
  Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. P