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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151011918), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryJun 19, 2019Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  TWO WEEKS AFTER FACIAL RESURFACING, THE PATIENT BEGAN EXPERIENCING ADDITIONAL INFLAMMATION, REDNESS, DISCOLORATION AND INCREASED PAIN AND SENSITIVITY OF THE FACE.

  Patient problems: Injury; Skin Discoloration

  MAUDE report 8712686 ↗

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-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-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