J-PLASMA PRECISERecalls & reported problems across all models
Aspen Surgical Products, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 7 models of J-PLASMA PRECISE by Aspen Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2018 and Mar 5, 2021 — classified as 16 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported J-PLASMA PRECISE problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Use of Device Problem6
- Improper or Incorrect Procedure or Method4
- Insufficient Device Problem Information4
- Detachment Of Device Component2
- Human Factors Issue2
- Off-Label Use2
- Backflow1
Patient problems
- Injury6
- Burn(s)5
- Patient Problem/Medical Problem5
- Hematoma2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Partial thickness (Second Degree) Burn2
- Adhesion(s)1
J-PLASMA PRECISE models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- J-PLASMA® PRECISE™ BVX-150BElectrosurgical, Cutting & Coagulation & Accessories5 reports
- J-PLASMA® PRECISE™ BVX-330BElectrosurgical, Cutting & Coagulation & Accessories5 reports
- J-PLASMA® PRECISE™ BVX -150-BPSElectrosurgical, Cutting & Coagulation & Accessories4 reports
- J-PLASMA® PRECISE™ BVX -150-BPPElectrosurgical, Cutting & Coagulation & Accessories3 reports
- J-PLASMA® PRECISE™ BVX-330BRElectrosurgical, Cutting & Coagulation & Accessories2 reports
- J-PLASMA® PRECISE™ BVX-044-BPSElectrosurgical, Cutting & Coagulation & Accessories1 report
- J-PLASMA® PRECISE™ BVX-044-BPPElectrosurgical, Cutting & Coagulation & Accessories1 report
Recent J-PLASMA PRECISE adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT RECEIVED A SUBMENTAL BURN AFTER A LIPOSUCTION PROCEDURE FOLLOWED BY RENUVION.
Patient problems: Burn(s); Injury
MAUDE report 9615863 ↗InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD PNEUMOTHORAX AFTER A J-PLASMA PROCEDURE ON NECK, ARMS AND ABDOMEN.
Patient problems: Patient Problem/Medical Problem; Pneumothorax
MAUDE report 9574243 ↗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 ↗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 ↗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 ↗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 ↗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 ↗InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT FOR A SUBCUTANEOUS HEMATOMA ON LEFT CHEST AFTER SURGERY. ASPIRATION PERFORMED WITH NO RETURN OF FLUID.
Patient problems: Bruise/Contusion; Hematoma; Injury
MAUDE report 8612136 ↗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 ↗
Other Aspen Surgical Products, Inc. products
All Aspen Surgical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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