J-PLASMA® PRECISE™ BVX-044-BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151011864), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  IN THE UNITED STATES, THE PATIENT PRESENTED WITH A HYPERTROPHIC SCAR OVER THE JAWLINE APPROXIMATELY 3 CM BY .5 CM DUE TO A BURN THAT APPEARED AFTER A DERMAL RESURFACING PROCEDURE. THE DOCTOR TREATED THE PATIENT WITH CONSERVATIVE THERAPIES INCLUDING STEROID INJECTIONS. DERMAL RESURFACING IS AN OFF LABEL USE OF THE DEVICE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 11421839 ↗

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-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
• 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
• Z-1156-2018 · Feb 8, 2018 · Terminated
  J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR