SculpSure laser assembly 100-7026-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841494100032), received between Jan 5, 2018 and Mar 22, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED ERYTHEMA AND EDEMA ON THE OUTER THIGH AREA FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE. PATIENT ALSO REPORTS THAT THE TREATMENT AREA IS TENDER TO TOUCH 6 DAYS POST TREATMENT.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 18958597 ↗
• InjuryAug 3, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE UMBILICAL AREA FOLLOWING A NON-INVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE.

  Patient problems: Burn(s)

  MAUDE report 15156286 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A NODULE IN THE LOWER ABDOMEN AREA FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE. SITE REPORTS ITS BEEN OVER 11 MONTHS NOW AND NODULE IS STILL PRESENT.

  Patient problems: Nodule

  MAUDE report 12961505 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD RECEIVED A SCULPTURE TREATMENT OVER A YEAR AGO AND NODULE IS STILL PRESENT. PATIENT RECEIVED MEDICAL INTERVENTION AS A RESULT OF PERSISTENT NODULE.

  Patient problems: Nodule

  MAUDE report 12242693 ↗
• InjuryJul 28, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE FLANK AREA FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPTURE. BURN WAS OBSERVED IN THE PATIENT'S SKIN FOLD.

  Patient problems: Scar Tissue

  MAUDE report 12242276 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH CELLULITIS FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9866468 ↗
• InjuryFeb 5, 2019Use of Device Problem; Use of Device Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8304615 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMED OF AN ALLEGED KIDNEY INFECTION FOLLOWING A LASER PROCEDURE. (PATIENT 2 OF 2).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8031047 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMED OF AN ALLEGED KIDNEY INFECTION FOLLOWING A LASER PROCEDURE. (PATIENT 1 OF 2).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8031044 ↗
• InjurySep 26, 2018Use of Device Problem; Use of Device Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE FOR SWELLING/PAIN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7911697 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7911676 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7870261 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A BURN ON THE FLANKS AREA FOLLOWING A LASER PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 7605085 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A BURN/BLISTER ON THE ABDOMEN FROM A LASER PROCEDURE.

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

  MAUDE report 7169546 ↗