SYLFIRM XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08809502330101), received between Jul 12, 2023 and Apr 14, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryApr 14, 2026Insufficient Device Problem Information

  THIS REPORT IS A FOLLOW UP REPORT OF MW5184413. INCIDENT DETAILS: THE PATIENT CLAIMS THAT FAT LOSS, BURNING SENSATIONS, TIGHTNESS, SKIN INFLAMMATION, ENLARGED PORES, AND SCARRING OCCURRED FOLLOWING THE SYLFIRM X PROCEDURE. THE PATIENT STATES THAT THEY RECEIVED THREE SYLFIRM X TREATMENTS AND SUBSEQUENTLY UNDERWENT TESTS, INCLUDING A BRAIN MRI, WHICH TESTED POSITIVE FOR ANA. THE PATIENT CLAIMS THAT THESE RESULTS WERE CAUSED BY THE SYLFIRM X PROCEDURE. INVESTIGATION RESULTS: CUSTOMER COMPLAINTS: IT WAS FOUND THAT AMONG THE CUSTOMER FEEDBACK COLLECTED BY VIOLO, NO COMPLAINTS REGARDING THE SYMPTOMS CLAIMED BY THE PATIENT WERE RECEIVED. HOWEVER, FOUR PATIENT REPORTS CLAIMING FAT REDUCTION WERE SUBMITTED TO THE FDA; ONE CASE WAS A FALSE REPORT SEEKING COMPENSATION, AND THE INVESTIGATION PROCESS FOR THE REMAINING THREE CASES WAS SUSPENDED DUE TO THE INABILITY TO COLLECT INFORMATION TO DETERMINE THE CAUSE. FURTHER EXPLANATION REGARDING THE REMAINING THREE CASES IS AS FOLLOWS: 1) ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO DETERMINE THE CAUSE, BUT NO CONTACT WAS MADE (2 CASES). 2) DESPITE BEING ADVISED TO VISIT THE HOSPITAL TO ASSESS THE SITUATION, THE PATIENT AVOIDED THE RECOMMENDATION AND

  Patient problems: Insufficient Information

  MAUDE report 24879871 ↗
• InjuryMar 9, 2026Insufficient Device Problem Information

  THIS REPORT IS A FOLLOW-UP REPORT FROM THE MANUFACTURER REGARDING MW5182490. PATIENT REPORT DETAILS: THE PATIENT CLAIMS FAT LOSS AND SCARRING ON HER FACE AND NECK AFTER RECEIVING SYLFIRM X. THE PATIENT CLAIMS HER SKIN BECAME SO THIN THAT PULSES COULD BE SEEN UNDER THE SKIN OVER HER TRACHEA. SHE ALSO CLAIMS THAT THIS TREATMENT REVERSED THE EFFECTS OF ANOTHER DERMATOLOGICAL PROCEDURE SHE RECEIVED TWO YEARS PRIOR. INVESTIGATION RESULTS: CUSTOMER COMPLAINTS: AFTER REVIEWING CUSTOMER FEEDBACK COLLECTED BY VIOL CO., LTD, WE HAVE NOT IDENTIFIED ANY CUSTOMER COMPLAINTS RELATED TO FAT REDUCTION WITH SYLFIRM X. HOWEVER, THE FDA HAS RECEIVED THREE REPORTS OF PATIENTS CLAIMING FAT REDUCTION. IN ONE OF THESE CASES, THE SUBMITTED INFORMATION WAS DEEMED UNRELIABLE UPON REVIEW. IN THE REMAINING TWO CASES, THE INVESTIGATION WAS HALTED DUE TO FAILURE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION TO DETERMINE THE CAUSE, OR FAILURE TO COOPERATE WITH RECOMMENDATIONS TO VISIT A HEALTHCARE PROVIDER FOR FURTHER EVALUATION. THEREFORE, IN ALL THREE CASES, THE FACTS AND CAUSES OF FAT REDUCTION HAVE NOT BEEN FULLY CONFIRMED. TO DATE, NO CUSTOMER COMPLAINTS RELATED TO FAT REDUCTION WITH SYLFIRM X HAVE BEEN

  Patient problems: Insufficient Information

  MAUDE report 24554446 ↗
• InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION INVESTIGATED SO FAR, IT IS DIFFICULT TO CONFIRM WHETHER THE SIDE EFFECTS CLAIMED BY THE PATIENT WERE CAUSED BY SYLFIRM X, SO FURTHER INVESTIGATION IS NECESSARY. THE RESULTS OF THE INVESTIGATION SO FAR ARE AS FOLLOWS. 1. BASED ON THE MEDWATCH(MW5167590) CONTENT (CONTACTED VIA VIOL'S REPRESENTATIVE EMAIL) REPORTED BY THE PATIENT, NEITHER VIOL NOR VIOL'S DISTRIBUTOR, (B)(6), HAVE RECEIVED EMAILS WITH SUCH CONTENT. 2. THE PATIENT RECEIVED A TOTAL OF 4 TIMES SYLFIRM X TREATMENTS FROM (B)(6) 2023 TO (B)(6) 2024, AND THE CONDITIONS FOR THE 1ST TO 3RD TREATMENTS WERE ALL THE SAME. THEREFORE, IF THESE SIDE EFFECTS OCCURRED DUE TO THE SYLFIRM X TREATMENT, THE SIDE EFFECTS SHOULD HAVE OCCURRED FROM THE 1ST TREATMENT. HOWEVER, THE PATIENT RECEIVED THREE ADDITIONAL TREATMENTS AFTER THAT, WHICH SUGGESTS THAT THE SIDE EFFECTS DID NOT OCCUR IN THE 1ST TO 3RD TREATMENTS. HOWEVER, SINCE INFORMATION ON THE 4TH PROCEDURE HAS NOT BEEN COLLECTED YET AND ONLY THE BEFORE PHOTO WAS PROVIDED BY THE HOSPITAL, IT IS NECESSARY TO CONFIRM WHETHER THE PROCEDURE CONDITIONS CHANGED IN THE 4TH PROCEDURE AND WHETHER SIDE EFFECTS OCCURRED BY COMPARING IT TO THE AFTER PHOTO. THEREFORE, FOR THE

  Patient problems: Insufficient Information

  MAUDE report 21896773 ↗
• InjuryJul 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 15, 2023, VIOL CO.,LTD RECEIVED AN OFFICIAL LETTER FROM THE FDA THAT AN INCIDENT REPORT HAD BEEN RECEIVED. BASED ON THE CONTENTS OF THE OFFICIAL LETTER AND RELATED MEDWATCH REPORT (MW5118363), AN INVESTIGATION WAS CONDUCTED WITH (B)(4) AN IMPORTER, AND THE FOLLOWING WERE CONFIRMED. IN THE REPORT (MW5118363), THE REPORTER SAID THAT HE/SHE COMPLAINED ON VIOL'S SOCIAL MEDIA, SO (B)(4) AND VIOL'S SOCIAL MEDIA WERE INVESTIGATED. AS A RESULT OF THE INVESTIGATION, IT WAS CONFIRMED THAT TWO INQUIRIES WERE MADE ON (B)(4) SOCIAL MEDIA WITH SIMILAR CONTENT TO THE RELATED REPORT (MW5118363). IN RELATIONI TO THIS, IT WAS CONFIRMED THAT (B)(4) WHO IS MANAGING THE SOCIAL MEDIA, GAVE SOME REPLIES TO THE INQUIRER. HOWEVER, THERE IS LITTLE INFORMATION IN THE REPORT (MW5118363), SO IT IS DIFFICULT TO CONFIRM WHETHER THE INQUIRER IS THE REPORTER OF MW5118363. FOR THIS REASON, IT IS DIFFICULT TO REQUEST THE HOSPITAL TO PROVIDE PATIENT INFORMATION RO PERSONAL INFORMATION OF THE INQUIRER. THEREFORE, WE REQUEST FDA TO PROVIDE THE REPORTER'S INFORMATION FOR FURTHER INVESTIGATION. IF FDA PROVIDES T HE REPORTER'S INFORMATION, ADDITIONAL INVESTIGATION WILL BE CONDUCTED AND FOLLOW-UP REPORT WILL BE MAD

  Patient problems: Insufficient Information

  MAUDE report 17313430 ↗