Morpheus8 Applicator AG607401ARecalls & reported problems
Inmode M.D Ltd · Morpheus8 Applicator · Class 2
Quick summary
This InMode Morpheus8 applicator is used for skin treatments. Reports mostly describe lasting redness, dark or light marks in the pattern of the needles, scarring and allergic reactions on the face, and a mention of a sterile tip reused on a different patient. There are 24 reports naming its identifier, with no deaths and 24 injuries mentioned. No recalls name this device, with 2 reports in the recent year compared with 8 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07290016633412), received between Feb 16, 2023 and Jun 10, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information12
- Adverse Event Without Identified Device or Use Problem8
- Use of Device Problem5
- Use of Incorrect Control/Treatment Settings4
- Improper or Incorrect Procedure or Method2
- No Apparent Adverse Event1
Patient problems
- Erythema7
- Hypersensitivity/Allergic reaction5
- Scar Tissue5
- Hyperpigmentation4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Hypopigmentation2
- Impaired Healing2
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Insufficient Device Problem Information
A FEMALE PATIENT PRESENTING WITH PIH/PIE REPLICATING MORPHEUS8 NEEDLE INSERTION SITES ON FACE AND UPPER NECK. 8 MONTHS POST TREATMENT.
Patient problems: Erythema; Hyperpigmentation; Impaired Healing
MAUDE report 25454102 ↗InjuryJun 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THREE DAYS AFTER THE STERILE TIP WAS USED ON A PATIENT, THE SAME STERILE TIP WAS RE-USED ON A DIFFERENT PATIENT, RESULTING IN A POTENTIAL EXPOSURE TO PATHOGENS. UPON DISCOVERY OF THE DEVICE REUSE, THE PATIENT WAS NOTIFIED AND ENCOURAGED TO SEEK APPROPRIATE MEDICAL TREATMENT AND TESTING. AT THE TIME OF THIS REPORT, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Exposure to Body Fluids
MAUDE report 22307613 ↗InjuryApr 23, 2025Use of Device Problem; Use of Device Problem
InjuryApr 10, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
PIE, PIH AND UNEVEN SKIN TEXTURE ON FACE 5 MONTHS POST MOPRHEUS8 TREATMENT.
Patient problems: Erythema; Hyperpigmentation; Scar Tissue
MAUDE report 21811740 ↗InjuryJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS REPORT IS SUBMITTED FOLLOWING PATIENT'S REPORT TO FDA MW5164341, CLAIMING "MY SCARS GOT WORSE AND CAUSED MORE SCARRING" 1.5 YEARS POST MORPHEUS8 TREATMENT.
Patient problems: Scar Tissue
MAUDE report 21261957 ↗InjuryDec 24, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLERGIC REACTION 48HRS POST MORPHEUS8 TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21011012 ↗InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLERGIC REACTION 48HRS POST MORPHEUS8 TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20805238 ↗InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLERGIC REACTION 24HRS POST MORPHEUS8 TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20804945 ↗InjuryNov 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
BURNS DUE TO USING MORPHEUS8 IN PROXIMITY WITH OXYGEN AND ALCOHOL.
Patient problems: Burn(s)
MAUDE report 20672511 ↗InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PROLONGED PIE ON FACE FOLLOWING MORPHEUS8 TREATMENT.
Patient problems: Erythema
MAUDE report 20329762 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PIE AND PIH ON FOREHEAD AND ABDOMEN 1 YEAR POST MORPHEU8 TX FOR FACE, AND 10-11 MONTHS POST MORPHEUS8 TX FOR ABDOMEN.
Patient problems: Erythema; Hyperpigmentation
MAUDE report 20245294 ↗InjuryAug 21, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
PAPULAR TIP FOOTPRINTS WITH PIE ON DÉCOLLETÉ 7 MONTHS POST MORPHEUS8 TREATMENT.
Patient problems: Erythema; Granuloma; Skin Inflammation/ Irritation
MAUDE report 20021746 ↗InjuryJul 21, 2024Use of Device Problem; Use of Device Problem
PIH/PIE OVER FACE 9 MONTHS POST MORPHEUS8 TREATMENT.
Patient problems: Erythema; Hyperpigmentation
MAUDE report 19788610 ↗InjuryJul 17, 2024Use of Device Problem; Use of Device Problem
NECROTIC LESIONS AT INJECTION SITES OF ANESTHETIC SOLUTION FOLLOWING MORPHEUS8 TREATMENT
Patient problems: Localized Skin Lesion; Necrosis
MAUDE report 19758676 ↗InjuryJun 20, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
InjuryMar 4, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
NECK PAIN AND MUSCLE TENSION ON THE LEFT SIDE 1 YEAR POST MORPHEUS8 TREATMENT.
Patient problems: Neck Pain
MAUDE report 18824500 ↗InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALLERGIC REACTION STARTING ON DAY 5 AFTER MORPHEUS8 TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18324576 ↗InjuryNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THIS COMPLAINT WAS INITIALLY SUBMITTED BY A PATIENT DIRECTLY TO FDA (MW5146472) REGARDING A TREATMENT WITH MORPHEUS8 SHE UNDERWENT IN (B)(6) 2022 TO REDUCE FACIAL SCARS FOLLOWING A CAR ACCIDENT THAT HAPPENED 20 YEARS AGO. THE PATIENT COMPLAINED ABOUT SKIN BURNING SENSATION, ELASTICITY AND FAT LOSS, SCARRING, FEELING SUICIDAL AND ORANGE-PEEL TEXTURED SKIN. THE PATIENT STATES THAT SHE HAS SEEN SOME IMPROVEMENT IN HER CONDITION FOLLOWING FILLERS AND CHEMICAL PEELS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Scar Tissue; Skin Inflammation/ Irritation; Suicidal Ideation
MAUDE report 18048320 ↗InjuryOct 3, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
RESIDUAL PIE IN THE SHAPE OF THE TIP FOOTPRINTS LOCATED IN THE LOWER ABDOMEN ONE AND A HALF YEAR AFTER TREATMENT WITH MORPHEUS8.
Patient problems: Erythema
MAUDE report 17859176 ↗InjuryAug 29, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THIS COMPLAINT WAS INITIALLY REPORTED BY THE PATIENT DIRECTLY TO FDA ON 04-JAN-2023 (MW5114225) AND STATED: "I RECEIVED A MORPHEUS 8 MICRO NEEDLING TREATMENT ON MY FACE WHICH RESULTED IN UNWANTED PERMANENT FAT LOSS, CHANGES IN MY FACE STRUCTURE, INDENTATIONS IN MY FACE WHICH WILL REQUIRE SURGICAL REPAIR. I ALSO EXPERIENCED SEVERE HEAD PAIN AND HAD A BRAIN MRI FOLLOWING THE TREATMENT.".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Headache; No Clinical Signs, Symptoms or Conditions
MAUDE report 17640344 ↗InjuryAug 21, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
PAPULAR LESIONS IN THE SHAPE OF THE TIP FOOTPRINT IN THE CENTRAL REGION OF THE FOREHEAD AND OVER THE NECK.
Patient problems: Impaired Healing
MAUDE report 17583494 ↗InjuryMay 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
HYPOPIGMENTED LESIONS IN THE SUBMENTAL AND NECK AREA, ABOUT 1 MONTH POST MORPHEUS8 TREATMENT, AND ERYTHEMATOUS AREAS (TIP FOOTPRINTS) IN THE LATERAL AND MEDIAL ASPECT OF THE NECK. IN ADDITION TO THE REPORT MADE BY THE CLINIC TO INMODE'S CALL CENTER, THE PATIENT HERSELF MADE A VOLUNTARY REPORT TO THE FDA (MW5117220) DATED APRIL 28, COMPLAINING ABOUT "SWELLING, PAIN, AND ITCHING AND STILL HAD REDNESS A MONTH LATER".
Patient problems: Hypopigmentation
MAUDE report 16928239 ↗InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEVERE ALLERGIC REACTION OVER FACE AND DECOLLETE IN POST TREATMENT PHASE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16386209 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.