Ignite RF System AG613237ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07290019863250), received between Dec 11, 2024 and Jun 24, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (22 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Use of Device Problem

  A FEMALE PATIENT SUSTAINING A FULL THICKNESS BURN WITH NECROSIS ON THE RIGHT MEDIAL BRACHIAL REGION (FEW CM ABOVE THE ELBOW) FOLLOWING TREATMENT WITH BODYTITE.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 25606118 ↗
• InjuryJun 15, 2026Insufficient Device Problem Information

  A DOCTOR REPORTED OF A FEMALE PATIENT TREATED WITH FACETTE ON HER FACE AND SUSTAINING A SMALL BURN ON HER RIGHT JOWL (THAT HEALED WITH NO SEQUELAE), AND AN ABSCESS THAT RESOLVED FOLLOWING TREATMENT WITH ANTIBIOTICS, LEAVING AN INDURATION (MOST PROBABLY A FIBROTIC LUMP) IN THE SUBMENTUM.

  Patient problems: Abscess; Fibrosis; Superficial (First Degree) Burn

  MAUDE report 25498820 ↗
• InjuryMay 31, 2026Use of Device Problem

  A male patient presenting with a full thickness burn on his right submentum following Quantum 10 treatment.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25344628 ↗
• InjuryMay 27, 2026Use of Device Problem

  10 DAYS POST PROCEDURE, A CLINIC REPORTED OF A PATIENT SUSTAINING POSSIBLE MUSCLE DAMAGE DURING USAGE OF QUANTUM 10, WHILE THE DOCTOR WAS PERFORMING TUNNELING (WITHOUT RF DELIVERY). THE PATIENT WAS BEING TREATED AGGRESSIVELY ON HIS RIGHT SIDE OF THE FACE AND APPARENTLY THE DOCTOR MOVED TOO DEEP WITH THE DEVICE CAUSING INTENSE PAIN IN THE PATIENT. LATER, THE PATIENT REPORTED INTENSE PAIN DURING CHEWING.

  Patient problems: Difficulty Chewing; Muscle/Tendon Damage

  MAUDE report 25298081 ↗
• InjuryMay 10, 2026Use of Device Problem; Insufficient Device Problem Information

  A 69 year old female patient complained to FDA about sustaining third degree burns on her submentum and neurapraxia of the marginal mandibular branch of the facial nerve, 1 month following treatment with Quantum RF.

  Patient problems: Full thickness (Third Degree) Burn; Peripheral Nervous Injury

  MAUDE report 25133270 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  A DOCTOR REPORTED OF 3 PATIENTS PRESENTING WITH NEUROPATHY SYMPTOMS (PERSISTENT, DAILY TINGLING AND SHOOTING PAIN IN THE ARMS AND THIGHS) FOLLOWING TREATMENT COMBINING LIPOSUCTION WITH QUANTUM 25. THIS COMPLAINT IS FOR PATIENT #3.

  Patient problems: Neuropathy

  MAUDE report 24924530 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  A DOCTOR REPORTED OF 3 PATIENTS PRESENTING WITH NEUROPATHY SYMPTOMS (PERSISTENT, DAILY TINGLING AND SHOOTING PAIN IN THE ARMS AND THIGHS) FOLLOWING TREATMENT COMBINING LIPOSUCTION WITH QUANTUM 25. THIS COMPLAINT IS FOR PATIENT #1.

  Patient problems: Neuropathy

  MAUDE report 24924529 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  A DOCTOR REPORTED OF 3 PATIENTS PRESENTING WITH NEUROPATHY SYMPTOMS (PERSISTENT, DAILY TINGLING AND SHOOTING PAIN IN THE ARMS AND THIGHS) FOLLOWING TREATMENT COMBINING LIPOSUCTION WITH QUANTUM 25. THIS COMPLAINT IS FOR PATIENT #2.

  Patient problems: Neuropathy

  MAUDE report 24924528 ↗
• InjuryApr 19, 2026Adverse Event Without Identified Device or Use Problem

  TREATMENT PROVIDER REPORTED OF A FEMALE PATIENT DEVELOPING A SECONDARY INFECTION IN HER RIGHT ANTEROMEDIAL THIGH FOLLOWING TREATMENT WITH QUANTUM 25. ON THE PROVIDED PHOTO OF 7 DAYS POST TX, A LARGE INFLAMED RED AREA CAN BE SEEN, CONSISTENT WITH CELLULITIS. ACCORDING TO THE TREATMENT PROVIDER, THE PATIENT IS CURRENTLY TAKING ANTIBIOTICS AND SEEMS TO BE IMPROVING.

  Patient problems: Cellulitis

  MAUDE report 24921020 ↗
• InjuryApr 14, 2026Use of Device Problem

  A DOCTOR COMPLAINED ABOUT A FEMALE PATIENT SUSTAINING A "PARTIAL PARALYSIS OF HER MARGINAL MANDIBULAR NERVE" PERSISTING FOR 2 WEEKS POST QUANTUM RF TREATMENT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 24869675 ↗
• InjuryMar 30, 2026Use of Device Problem; Insufficient Device Problem Information

  A 60-year-old female patient treated with quantum 10 on her submentum for fat reduction and skin tightening, presenting with fibrotic lump of 3cm in diameter in the central part of the submentum, 5 months post treatment.

  Patient problems: Fibrosis

  MAUDE report 24725650 ↗
• InjuryMar 23, 2026Use of Device Problem

  FEMALE PATIENT PRESENTING WITH A HYPERTROPHIC SCAR FOLLOWING PARTIAL THICKNESS BURN ON THE ARM FOLLOWING BODYTITE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 24659897 ↗
• InjuryMar 19, 2026Use of Device Problem; Insufficient Device Problem Information

  A FEMALE PATIENT SUSTAINING NEURAPRAXIA FOLLOWING QUANTUM 10 PROCEDURE ON HER FACE.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 24636829 ↗
• InjuryMar 11, 2026Use of Device Problem; Insufficient Device Problem Information

  A DOCTOR REPORTED TO INMODE ABOUT A 62-YEAR-OLD FEMALE PATIENT TREATED WITH QUANTUM RF ON HER LOWER FACE AND JOWLS, DIAGNOSED WITH PAROTITIS WITH INFECTION. PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON IV ANTIBIOTICS, RECEIVED A DOSE OF IV STEROIDS. INCISION AND DRAINAGE HAVE BEEN PERFORMED WITH PERSISTENT RE-ACCUMULATION OF FLUIDS. ~1 WEEK LATER, THE PATIENT WAS INJECTED 30 UNITS OF BOTOX DIRECTLY INTO THE PAROTID GLAND AND STARTED ON GLYCOPYRROLATE ORALLY FOR SALIVARY GLAND SUPPRESSION.

  Patient problems: Cellulitis; Salivary Gland Problem

  MAUDE report 24574705 ↗
• InjuryMar 9, 2026Use of Device Problem

  FULL THICKNESS BURN WITH NECROSIS ON SUBMENTUM FOLLOWING QUANTUM PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 24545530 ↗
• InjuryFeb 22, 2026Insufficient Device Problem Information

  AN ANONYMOUS PATIENT REPORT SUBMITTED TO FDA (MW5182363 AND MW5182364). A 56-YEAR-OLD FEMALE PATIENT COMPLAINS ABOUT BURN MARKS, SCARRING AND PROLONGED SEVERE PAIN FOLLOWING TREATMENT WITH QUANTUM RF FOR SKIN TIGHTENING ON BOTH ARMS, PERFORMED 1 YEAR AGO. THE SCARRING IS "SIMILAR TO 3RD DEGREE BURN", ACCORDING TO THE PATIENT. ADDITIONALLY, THE PATIENT COMPLAINS ABOUT LYMPHATIC DAMAGE: "MY LYMPH NODES NO LONGER DRAIN PROPERLY. I HAVE TO WEAR COMPRESSION DEVICES AND HAVE REGULAR LYMPHATIC DRAINAGE MASSAGES AND ULTRASONIC MASSAGES TO RELIEVE THE PAIN.".

  Patient problems: Full thickness (Third Degree) Burn; Pain; Scar Tissue; Unspecified Blood or Lymphatic problem

  MAUDE report 24410500 ↗
• InjuryFeb 19, 2026Use of Device Problem; Insufficient Device Problem Information

  A FULL THICKNESS BURN WITH NECROSIS AT THE NAVEL OF A FEMALE PATIENT FOLLOWING PROCEDURE THAT INCLUDED LIPOSUCTION, FOLLOWED BY BODYTITE AND MORPHEUS8.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 24387056 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A FEMALE PATIENT TREATED WITH QUANTUM 25 AND MORPHEUS8 ON THE SAME SESSION ON HER ABDOMEN. ACCORDING TO THE TREATMENT PROVIDER, "NO BLEEDING, PAIN, OR INCIDENT DURING OR IMMEDIATELY AFTER PROCEDURE. " WERE NOTED. THREE DAYS POST PROCEDURE, THE PATIENT INFORMED THE TREATMENT PROVIDER THAT SHE'S BEEN "AGGRESSIVELY MASSAGING LLQ AND FELT "POP" AND KEPT DOING IT. ". ALTHOUGH ADVISED BY THE PROVIDER TO AVOID THESE ACTIONS, THE PATIENT CONTINUED "TO TRY TO "MILK" THE AREA FROM INCISION.". THE TREATMENT PROVIDER SUSPECTED A SEROMA. FIFTEEN DAYS POST TX, PATIENT'S HUSBAND INFORMED THE TREATMENT PROVIDER THAT "THE CLIENT WAS HOSPITALIZED DUE TO HEMATOMA". THE HEMATOMA WAS DRAINED ON THE 6TH DAY IN THE HOSPITAL AND THE PATIENT WAS RELEASED ON DAY 10. AT DAY 38 POST TX, THE PATIENT'S STATUS IS STABLE.

  Patient problems: Hematoma; Seroma

  MAUDE report 24187560 ↗
• InjuryJan 22, 2026Use of Device Problem

  A FEMALE PATIENT COMPLAINED ABOUT NEUROPATHIC PAIN RADIATING ALONG THE ULNAR NERVE 5 DAYS FOLLOWING THE QUANTUMRF PROCEDURE ON HER ARMS. PATIENT IS CURRENTLY ON PREGABALIN & VIT B COMPLEX.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 24143704 ↗
• InjuryDec 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A TREATMENT PROVIDER REPORTED OF A FEMALE PATIENT WITH "A NERVE AFFECTED UNDER HER MOUTH" FOLLOWING TREATMENT WITH QUANTUM 10. ACCORDING TO THE PROVIDER "IT'S BEEN SEVERAL WEEKS. "

  Patient problems: Nerve Damage

  MAUDE report 23860321 ↗
• InjuryNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINIC REPORTED OF AN ALLEGED BURN AND SCARRING FOLLOWING ACCUTITE TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn; Scar Tissue

  MAUDE report 23664067 ↗
• InjuryNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FULL THICKNESS BURN WITH NECROSIS SITUATED ON THE RIGHT JAWLINE, ALLEGEDLY FOLLOWING QUANTUMRF PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 23642363 ↗
• InjuryNov 13, 2025Use of Device Problem; Use of Device Problem

  MILD NEURAPRAXIA MANIFESTED AS MILD ASYMMETRY OF THE RIGHT SIDE OF THE MOUTH AND SLOW RIGHT LIP RESPONSE, FOLLOWING FACETITE PROCEDURE.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 23541634 ↗
• InjuryNov 3, 2025Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  BURN ON ARM AND EDEMA ON BRALINE FOLLOWING QUANTUM PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 23446959 ↗
• InjuryOct 27, 2025Use of Device Problem; Use of Device Problem

  FULL THICKNESS BURNS WITH NECROSIS ON THE JAWLINE FOLLOWING QUANTUM PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 23388652 ↗