InMode RF hand piece HP101306ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17290016633211), received between Jul 16, 2021 and May 18, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  3RD DEGREE BURN DEVELOPED FOLLOWING TREATMENT WITH FACETITE, LOCATED IN THE CENTRAL ANTERIOR AREA OF THE NECK. THE ABLATIVE LESION, ROUNDED WITH A DIAMETER OF ABOUT 2 CM, APPEARS DECORTICATED OF THE DERMIS. PROPHYLACTIC MEDICAL INTERVENTION REQUIRED TO AVOID SECONDARY INFECTION AND FACILITATE WOUND HEALING. SCAR FORMATION CANNOT BE RULED OUT AT THE MOMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16953031 ↗
• InjuryFeb 17, 2023Use of Device Problem; Use of Device Problem

  EVIDENT NEURAPRAXIA IN THE RIGHT LOWER LIP AFTER A FACETITE TREATMENT ON (B)(6) 2021.

  Patient problems: Movement Disorder

  MAUDE report 16395171 ↗
• InjuryFeb 17, 2023Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  A TISSUE NECROSIS IN THE SUPRAPUBIC REGION (MONS) FOLLOWING A REDUCTION TREATMENT WITH BODYTITE. SUSPICIOUS FOR ERYSIPELAS AS THE UNDERLYING TISSUE BLANCHED FEW DAYS AFTER. A WEEK LATER, THE WOUNDS EVOLVED AND PSEUDOESCHAR WAS SEEN. IN THE LAST PHOTO THERE IS SIGNIFICANT STRAW-COLORED DRAINAGE, POSSIBLY A SMALL SEROMA DRAINING FROM A FULL THICKNESS WOUND.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16395050 ↗
• InjuryJul 16, 2021Improper or Incorrect Procedure or Method

  PATIENT RIGHT SIDE OF MOUTH SAGGING POST FACETITE TREATMENT. EVIDENT NEURAPRAXIA IN THE RIGHT LOWER LIP AFTER A FACETITE TREATMENT ON FEBRUARY 11TH. BASED ON OUR PAST EXPERIENCE, IN SUCH CASES, THE NATURE OF THE INJURY IS ALMOST ALWAYS TRANSIENT. DOCTOR (B)(6) REFUSES TO COLLABORATE WITH OUR REPRESENTATIVES AND WOULD NOT FILL IN THE CCQ, NEITHER ACCEPT A TECHNICAL INSPECTION OF THE SYSTEM. MANUFACTURER CASE INVESTIGATION: FURTHERMORE, HE HAS ANNOUNCED THAT HE NO LONGER INTENDS TO USE THIS TECHNOLOGY. THE NEURAPRAXIA THAT OCCURRED IN THIS EVENT MAY HAVE ARISEN FROM AN INVOLUNTARY IMPACT OF THE INSTRUMENT IN THE MANDIBULAR MARGINAL NERVE WHICH IN A CERTAIN POINT ALONG THE MANDIBULAR LINE PROTRUDES IN A SUPERFICIAL POSITION. THIS RESULTS IN A TEMPORARY NEUROPATHY WHICH USUALLY RESOLVES SPONTANEOUSLY WITHIN 2 - 3 MONTHS. IT IS THEREFORE TO BE CONSIDERED A MECHANICAL USER ERROR RELATED TO AN INCORRECT MANEUVER OF THE CANNULA IN THE AREA OF THE PATH OF THE MARGINAL MANDIBULAR NERVE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Neuralgia; Neuropathy

  MAUDE report 12188979 ↗