GentleWave Console FG-002-00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858395006226), received between Feb 3, 2018 and Jun 19, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SONENDO BECAME AWARE OF A MEDWATCH REPORT SUBMITTED TO THE FDA (REPORT #MW5170061) REGARDING A POSSIBLE ADVERSE EVENT INVOLVING THE GENTLEWAVEË SYSTEM USED ON TOOTH #15. THE REPORT SUGGESTS A POTENTIAL HYPOCHLORITE-RELATED REACTION. THE DATE OF THE INCIDENT WAS STATED AS JUNE 1, 2021. HOWEVER, NO IDENTIFYING INFORMATION REGARDING THE OFFICE LOCATION, SERIAL NUMBER OF THE GENTLEWAVE CONSOLE, OR LOT NUMBER OF THE DISPOSABLE HANDPIECE WAS PROVIDED. MY ENDODONTIST, DR. (B)(6) OF (B)(6), USED THE GENTLEWAVE SYSTEM BY SONENDO, INC. (HTTPS:// GENTLEWAVE.COM/) TO CLEAN AND PREPARE A ROOT CANAL FOR TOOTH 15. THE HIGHLY PRESSURIZED HYDRAULICALLY CONTROLLED SODIUM HYPOCHLORITE (BLEACH) FROM THIS MACHINE SPRAYED BLEACH INTO MY LEFT MAXILLARY SINUS CAUSING A SEVERE BURN IN MY LEFT MAXILLARY SINUS WHEREBY I HAD BLOOD AND BLEACH COMING OUT OF MY LEFT NOSTRIL. I SUSTAINED A SEVERE CHEMICAL BURN IN MY LEFT MAXILLARY SINUS WITH SEVERE DAMAGE TO BOTH TISSUES AND NERVES IN MY MAXILLARY SINUS AND NEARBY TISSUES LEADING TO CHRONIC SINUSITIS AND NEURALGIA, INCLUDING TRIGEMINAL NEURALGIA, IN THE LEFT PART OF MY FACE UNDER MY LEFT EYE. THE PAIN FROM THE INCIDENT RADIATES AROUND MY LEFT EYE AND SOMETIMES CA

  Patient problems: Blurred Vision; Caustic/Chemical Burns; Discomfort; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Nerve Damage; Neuralgia; Sinus Perforation; Sinusitis

  MAUDE report 22293848 ↗
• InjuryMar 31, 2021Patient-Device Incompatibility

  SEE INITIAL REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphasia; Skin Burning Sensation

  MAUDE report 11599848 ↗
• InjuryApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR REPORTED THAT THE PATIENT HAD NOSE BLEEDING AFTER COMPLETING THE GENTLEWAVE PROCEDURE. THE NEXT DAY THE PATIENT REPORTED NASAL DRAINAGE; AND IT CONTINUED FOR TWO DAYS. AFTER TWO WEEKS, THE PATIENT WAS SENT TO AN ENT DOCTOR AND WAS DIAGNOSED WITH ORO-ANTRA FISTULA.

  Patient problems: Sinus Perforation

  MAUDE report 9984692 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAD A NECROTIC TOOTH #18 FOR AT LEAST A YEAR. THE TOOTH WAS ONLY SYMPTOMATIC TO THE PATIENT DURING PERCUSSION TESTING UNTIL RECENTLY WHEN SHE WAS EATING. PATIENT HAS LOST OTHER TEETH TO ROOT FRACTURES. THE DAY OF PROCEDURE, I INSTRUMENTED ALL CANALS AND BEGAN GW PROTOCOL. 2MIN INTO THE SODIUM CYCLE, SHE FELT SOME DISCOMFORT. WE STOPPED BUT FOUND NO LEAK OR CAUSE OF THE PAIN. SHE HAD FELT PRESSURE SLOWLY BUILDING UNTIL IT WAS PAIN. I TRIED ONCE MORE AND WITHIN A FEW SECONDS SHE FELT THE PAIN AGAIN. WE STOPPED IMMEDIATELY, REMOVED THE PLATFORM, PLACED CAOH AND TEMPORIZED. WHEN ANESTHETIC WORE OFF THAT DAY SHE REPORTED HAD PAIN THAT WAS CONSTANT AND INCREASED WITH BITING PRESSURE. SHE CAME BACK FOR AN EVAL AND PERCUSSION CAUSED TENDERNESS AS WELL AS PUSHING THE TOOTH LINGUALLY. BASED ON SYMPTOMS, THE DR. SUSPECTED A VERTICAL ROOT FRACTURE SO CHECKED AGAIN FOR ANY DEEP POCKETING, FOUND NONE AND COULD SEE NONE ON THE INSIDE OR OUTSIDE THE TOOTH. DR WANTED TO RULE OUT THE POSSIBLY OF INFECTION EVEN THOUGH THE SYMPTOMS WEREN'T NECESSARILY CONSISTENT WITH THAT. I PLACED HER ON CLINDAMYCIN AND SYMPTOMS STAYED THE SAME OR INCREASED SLIGHTLY FOR ABOUT A WEEK. PT REFERRED TO SPECIA

  Patient problems: Pain; Sensitivity of Teeth

  MAUDE report 9914501 ↗
• InjuryFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PROCEDURE WAS ON PATIENT'S UPPER MOLAR WITH LARGE MUCUS CYST ABOVE ROOT. THE DOCTOR SAID HE FOLLOWED THE RECOMMENDED GUIDELINES AND WHEN HE WAS 90 SECONDS INTO THE NAOCI CYCLE, THE PATIENT RAISED HER HAND AND SAID THAT SHE HAD FELT A SHOOTING PAIN AND TASTED FLUID DRAINING IN HER MOUTH. THE PAIN RESOLVED QUICKLY BUT THE DRAINAGE CONTINUED. THE DR. DISCONTINUED THE USE OF THE GENTLEWAVE AND RINSED WITH DISTILLED WATER. THE DRAINAGE PERSISTED, NO BLEEDING WAS NOTED BUT THE DR. WAS UNABLE TO STOP THE DRAINAGE SO HE MEDICATED THE TOOTH AND SENT THE PATIENT TO AN ENT IN THE BUILDING. THE PAIN DID RESOLVE PRIOR TO THE PATIENT LEAVING THE OFFICE BUT SOME SWELLING WAS NOTED. THE ENT DID A CT AND NOTED THAT EVERYTHING LOOKED THE SAME AS THE ORIGINAL CBCT DONE BY THE DR (INFECTION AT ROOT) WITH EXCEPTION THAT THE MUCUS CYST WAS NO LONGER PRESENT. PATIENT WAS SENT HOME WITH ANTIBIOTICS, PAIN MEDS AND STEROIDS. PATIENT RETURNED A WEEK LATER, SWELLING RESOLVED; PATIENT DENIED ANY ISSUES, TOOTH WAS CLEANED AND OBTURATED. NO FURTHER COMPLAINT.

  Patient problems: Fluid Discharge; Pain; Swelling

  MAUDE report 9736218 ↗
• InjuryMay 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING PATIENT EXAMINATION, THERE WAS A NEGATIVE RESPONSE TO COLD TEST, PERCUSSION AND PALPATION. RADIOGRAPHIC AND CBCT EXAMINATION CONFIRMED THE PRESENCE OF A LARGE PERIRADICULAR LESION AROUND THE ROOT OF TOOTH #9 AND A CALCIFIED PULP CHAMBER FLOOR. BASED ON THE FINDINGS, A DIAGNOSIS OF PULP NECROSIS WITH ASYMPTOMATIC APICAL PERIODONTITIS WAS MADE AND ROOT CANAL TREATMENT WITH GENTLEWAVE PROCEDURE WAS PLANNED. THE TOOTH WAS PREPARED FOR GENTLEWAVE PROCEDURE PER GENTLEWAVE PROTOCOL. ACCESS CAVITY WAS PREPARED, AND ROOT CANAL WAS INSTRUMENTED. THE DOCTOR MENTIONED THAT THE ROOT CANAL WAS EXTREMELY CALCIFIED, BUT HE WAS ABLE TO NEGOTIATE AND INSTRUMENT THE CANAL WITH NO SIGNIFICANT LOSS OF TOOTH STRUCTURE OR COMPLICATION. A GENTLEWAVE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO ISSUES OR COMPLAINT. ROOT CANAL WAS OBTURATED AND THE ACCESS CAVITY WAS PERMANENTLY SEALED. ON FRIDAY (B)(6) 2018, DR. (B)(6) WAS CONTACTED BY THE PATIENT STATING THAT SHE WAS EXPERIENCING PAIN IN THE AREA ASSOCIATED WITH THE SUBJECT TOOTH AND THE SYMPTOM WASN'T RESPONDING TO THE PRESCRIBED ANALGESIC, 600 MG IBUPROFEN Q4-6. THE DOCTOR EXPLAINED TO THE PATIENT THE POTENTIAL FLARE UP THAT

  Patient problems: Pain; Swelling

  MAUDE report 7498685 ↗
• InjuryFeb 3, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT TREATED EARLIER IN THE DAY HAD GONE TO THE HOSPITAL DUE TO SWELLING IN THE NECK, NO BRUISING OR BLEEDING WAS REPORTED. CUSTOMER SUBSEQUENTLY REPORTED THAT PATIENT WAS ADMINISTERED A BREATHING TUBE WHICH HAS SINCE BEEN REMOVED. THE CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED FORM THE HOSPITAL AND RETURNED HOME. ENDODONTIST (CUSTOMER/USER) INITIALLY STATED THAT SWELLING COULD HAVE BEEN DUE TO AN ALLERGIC REACTION TO ANESTHESIA. THE CUSTOMER SUBSEQUENTLY STATED THAT IT COULD BE A SODIUM HYPOCHLORITE INCIDENT. THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE PATIENT INDICATED FEELING PAIN AND THUS THE CUSTOMER RE-ANESTHETIZED THE PATIENT. AFTER ADMINISTERING MORE ANESTHESIA, THE CUSTOMER REPORTED THAT HE COMPLETED THE PROCEDURE AND NOTED THAT THE RESULTS LOOKED GOOD. THE CUSTOMER REPORTED THAT THE PATIENT WAS FINE AFTER THE PROCEDURE AND LEFT THE OFFICE WITHOUT ISSUE. SINCE THE TIME OF THE INITIAL EVENT, THE CUSTOMER HAS NOTED THAT THE PATIENT'S CONDITION IS IMPROVING.

  Patient problems: Airway Obstruction

  MAUDE report 7239913 ↗