XERFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08809447657981), received between Sep 11, 2025 and May 7, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT SPARKING OCCURRED ON A PATIENT FACE AND PATIENT FELT "POPPING SENSATION" DURING A TREATMENT USING XERF 2.0. TREATMENT WAS IMMEDIATELY STOPPED AND EFFECTOR TIP WAS REPLACED. SETTINGS USED FOR TREATMENT INCLUDED DEEP MODE, CRYO 1, LEVEL 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116707 ↗
• MalfunctionMay 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT SPARKING OCCURRED ON A PATIENT FACE AND PATIENT FELT "POPPING SENSATION" DURING A TREATMENT USING XERF 2.0. TREATMENT WAS IMMEDIATELY STOPPED AND EFFECTOR TIP WAS REPLACED. SETTINGS USED FOR TREATMENT INCLUDED DEEP MODE, CRYO 1, LEVEL 6. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM REACHED OUT TO THE SITE TO INVESTIGATE THE EVENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THE SITE DID NOT PROVIDE ANY ADDITIONAL INFORMATION. DUE TO LACK OF COMMUNICATION WITH THE SITE, CYNOSURE LUTRONIC CLINICAL TEAM COULD NOT PROVIDE CLINICAL SUPPORT. XERF TIP HAS NOT YET BEEN RETURNED FOR A DEVICE EVALUATION, BUT A PHOTO WAS PROVIDED DURING INITIAL COMMUNICATION. SURFACE DAMAGE WAS OBSERVED ON THE TIP. ONCE TIP HAS BEEN RETURNED AND EVALUATED, A CYNOSURE FIELD SERVICE ENGINEER (FSE) WILL BE ABLE TO IDENTIFY ROOT CAUSE. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE A MALFUNCTION OCCURRED AND COULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. WE ARE REPORTING THIS AS AN INITIAL MDR AND WILL SUBMIT A FINAL MDR ONCE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114265 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WAS BURNED DURING A TEST TREATMENT WITH XERF. XERF HANDPIECE WAS ALSO LEAKING ICD OUT OF THE TIP AND CANNISTERS WERE REGISTERING EMPTY EVEN WHEN HALF FULL.

  Patient problems: Burn(s)

  MAUDE report 24844572 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT A TREATMENT PROVIDER BURNED THEMSELVES WHILE TESTING WITH XERF. XERF HANDPIECE WAS ALSO LEAKING ICD OUT OF THE TIP AND CANNISTERS WERE REGISTERING EMPTY EVEN WHEN HALF FULL.

  Patient problems: Burn(s)

  MAUDE report 24844319 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WAS BURNED DURING A TEST TREATMENT WITH XERF. XERF HANDPIECE WAS ALSO LEAKING ICD OUT OF THE TIP AND CANNISTERS WERE REGISTERING EMPTY EVEN WHEN HALF FULL. ON (B)(6) 2026, A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND PERFORMED A DEVICE EVALUATION. FSE OBSERVED DEVICE WAS CONNECTED TO EXTENDED OUTLET ADAPTER WITH MULTIPLE DEVICES CONNECTED. ADVISED SITE TO MOVE DEVICE FROM ADAPTER TO A DIRECT OUTLET CONNECTION. FSE THEN INSPECTED THE HANDPIECE AND DID NOT FIND ANY DAMAGE VISIBLY OR INTERNALLY. FSE INSERTED CRYO INTO THE DEVICE AND SAW IT IMMEDIATELY LEAKING FROM THE HANDPIECE. TO RESOLVE THE ISSUE, FSE REPLACED THE HANDPIECE. FSE NOTES THAT THE CLIENT WAS NOT FULLY TRAINED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE SITE TO FURTHER INVESTIGATE THE EVENT. SITE SHARED THAT THE INITIAL TRAINING SCHEDULED FOR (B)(6) 2026 WAS NOT COMPLETED DUE TO TECHNICAL ISSUES. A RETRAINING SESSION WAS COMPLETED ON (B)(6) 2026. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THERE WAS NO ADDITIONAL INFORMATION MADE AVAILABLE FROM THE CUSTOMER SITE DESPITE MULTIPLE REQUESTS FROM CYNOSURE LUTRONIC CLINICAL. AS A RESULT, EX

  Patient problems: Burn(s)

  MAUDE report 24844316 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT A TREATMENT PROVIDER BURNED THEMSELVES WHILE TESTING WITH XERF. XERF HANDPIECE WAS ALSO LEAKING ICD OUT OF THE TIP AND CANNISTERS WERE REGISTERING EMPTY EVEN WHEN HALF FULL. ON 17 MARCH 2026, A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND PERFORMED A DEVICE EVALUATION. FSE OBSERVED DEVICE WAS CONNECTED TO EXTENDED OUTLET ADAPTER WITH MULTIPLE DEVICES CONNECTED. ADVISED SITE TO MOVE DEVICE FROM ADAPTER TO A DIRECT OUTLET CONNECTION. FSE THEN INSPECTED THE HANDPIECE AND DID NOT FIND ANY DAMAGE VISIBLY OR INTERNALLY. FSE INSERTED CRYO INTO THE DEVICE AND SAW IT IMMEDIATELY LEAKING FROM THE HANDPIECE. TO RESOLVE THE ISSUE, FSE REPLACED THE HANDPIECE. FSE NOTES THAT THE CLIENT WAS NOT FULLY TRAINED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE SITE TO FURTHER INVESTIGATE THE EVENT. SITE SHARED THAT THE INITIAL TRAINING SCHEDULED FOR FEBRUARY 19, 2026 WAS NOT COMPLETED DUE TO TECHNICAL ISSUES. A RETRAINING SESSION WAS COMPLETED ON MARCH 19, 2026. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THERE WAS NO ADDITIONAL INFORMATION MADE AVAILABLE FROM THE CUSTOMER SITE DESPITE MULTIPLE REQUESTS FROM CYNOSURE LUTRONIC CLINIC

  Patient problems: Burn(s)

  MAUDE report 24844308 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE FACE DURING TREATMENT PERFORMED ON (B)(6) 2026 WITH A XERF DEVICE. TIME THE DEVICE WAS SUBJECTED TO FULL FUNCTIONALITY TESTING, VERIFIED DEVICE SET UP AND CONFIRMED POWER MEASUREMENT. THE DEVICE WAS FOUND TO BE WORKING WITHIN PUBLISHED SPECIFICATIONS. VISUAL INSPECTION OF THE EFFECTOR TIP USED DURING TREATMENT OBSERVED A SMALL BLACK DOT ON THE TIPS SURFACE, WHICH WAS REPORTED TO NOT BE PRESENT PRIOR TO TREATMENT. AN IMAGE WAS TAKEN OF THIS DAMAGE, AND ITS LOCATION SUGGESTS CARBONIZATION OCCURRED AT THE NTC LINE TIP LOT AND MANUFACTURING DATE WAS CHECKED AND IT WAS CONFIRMED TO BE PRODUCED BEFORE THE IMPLEMENTATION OF THE RESISTANCE INSPECTION THAT WAS COMPLETED IN (B)(6) 2025. ONCE THE TIP HAS BEEN RETURNED AND EVALUATED; ROOT CAUSE CAN BE BETTER VERIFIED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT CLINIC FOR ADDITIONAL INFORMATION. IT WAS DETERMINED THAT THE TREATMENT PARAMETERS USED WERE WITHIN THE RECOMMENDED CLINICAL GUIDELINES OF THE QUICKSTART GUIDE (QSG). IT IS UNDETERMINED WHAT CAUSED THE REPORTED BURNING, IT IS POSSIBLE THAT THE EFFECTOR TIP MAY HAVE NOT HAD FULL CONTACT WITH THE TREATMEN

  Patient problems: Burn(s)

  MAUDE report 24783599 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE FACE DURING TREATMENT PERFORMED ON (B)(6) 2026 WITH A XERF DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24781378 ↗
• MalfunctionFeb 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TREATMENT, AFTER APPROXIMATELY 450 PULSES THE DEVICE RELEASED AN UNEXPECTED SOUND AND SPARK FROM THE EFFECTOR. THE TREATMENT WAS INTERRUPTED AND A BURN MARK ON THE EDGE OF THE EFFECTOR TIP WAS OBSERVED WHERE THE SPARK WAS REPORTED TO HAVE OCCURRED CAUSING A BURN ON THE PATIENTS SKIN. THE EFFECTOR WAS REPLACED AND TREATMENT CONTINUED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE DEVICE CALIBRATION WAS TESTED AND FOUND TO BE WORKING WITHIN PUBLISHED SPECIFICATIONS. HOWEVER, CUSTOMER PROVIDED IMAGES OF THE FIRST EFFECTOR TIP THAT WAS USED OBSERVED VISUAL DAMAGE. IT IS UNDETERMINED WHAT CAUSED THIS DAMAGE. THE TIP WAS REQUESTED FOR ADDITIONAL EVALUATION, HOWEVER, HAS NOT BEEN RETURNED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND DETERMINED THAT THE TREATMENT PARAMETERS USED FOR BOTH EFFECTOR TIPS WERE WITHIN THE NORMAL RANGES OUTLINED IN THE QUICKSTART GUIDE (QSG). THE PATIENT WAS EVALUATED BY THE TREATMENT CLINIC'S MEDICAL DIRECTOR AND RECEIVED PREVENTATIVE TREATMENT; IT WAS CONFIRMED THAT THE PATIENT HAS RECOVERED

  Patient problems: Burn(s)

  MAUDE report 24336638 ↗
• MalfunctionFeb 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TREATMENT, AFTER APPROXIMATELY 450 PULSES THE DEVICE RELEASED AN UNEXPECTED SOUND AND SPARK FROM THE EFFECTOR TIP. THE TREATMENT WAS INTERRUPTED AND A BURN MARK ON THE EDGE OF THE EFFECTOR TIP WAS OBSERVED WHERE THE SPARK WAS REPORTED TO HAVE OCCURRED CAUSING A REPORTED BURN ON THE PATIENTS SKIN. THE EFFECTOR WAS REPLACED AND TREATMENT CONTINUED.

  Patient problems: Burn(s)

  MAUDE report 24332414 ↗
• InjuryJan 22, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT FOLLOWING MONOPOLAR RADIOFREQUENCY TREATMENT ON THE FACE WITH A XERF DEVICE, THE TREATMENT PROVIDER OBSERVED A BLISTER ON THE UPPER LATERAL SIDE OF THE NEM PAD AREA.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24146038 ↗
• InjuryJan 22, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT FOLLOWING MONOPOLAR RADIOFREQUENCY TREATMENT ON THE FACE WITH A XERF DEVICE, THE TREATMENT PROVIDER OBSERVED A BLISTER ON THE UPPER LATERAL SIDE OF THE NEM PAD AREA. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER WHO REPORTED THAT THE PATIENT REPORTED A WARM SENSATION UNDER THE NEM PAD, HOWEVER, IT WAS TOLERABLE AND DID NOT INTERRUPT THE TREATMENT SESSION. THE BLISTERING WAS OBSERVED NEAR THE APPLIED DISPOSABLE PATCH AND BECAME VISIBLE NEAR THE END OF THE TREATMENT SESSION. THE CLINICAL DETAILS WERE REQUESTED ON MULTIPLE OCCASIONS, DESPITE THESE REQUESTS, THE TREATMENT PROVIDER DID NOT DISCLOSE ANY INFORMATION TO THE CLINICAL TEAM. THE OPERATORS MANUAL (OM) STATES THAT THAT "PATIENT RETURN PAD MUST BE THOROUGHLY ADHERED TO THE PROPER AREA OF THE PATIENT'S BODY AS SPECIFIED BY THE MANUFACTURER. AVOID BONY-PROMINENCES AND HAIR WHEN ADHERING THE PATIENT RETURN PAD TO THE PATIENT TO DECREASE THE RISK OF ADVERSE EFFECTS OR BURNS. PATIENT RETURN PAD CABLES SHOULD BE POSITIONED IN SUCH A WAY THAT THEY DO NOT COME INTO CONTACT WITH THE PATIENT OR OTHER CABLES." IMAGES OF THE PATIENT BURNS WERE PROVIDED ON 1/14/2026 AND WERE FOR

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24145263 ↗
• MalfunctionDec 31, 2025Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SKIN BURNING AND SCABBING AFTER XERF TREATMENT ON THE FACE.

  Patient problems: Burn(s)

  MAUDE report 23933926 ↗
• MalfunctionDec 31, 2025Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SKIN BURNING AND SCABBING AFTER XERF TREATMENT ON THE FACE. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM REVIEWED THE TREATMENT PARAMETERS USED AND CONFIRMED THAT THEY WERE WITHIN THE NORMAL APPROVED CLINICAL RANGE. THE PATIENT REPORTED THAT THE BURNING AND SCABBING WAS EXPERIENCED TWO DAYS POST TREATMENT AND LASTED FOR SEVEN DAYS. IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED. REVIEW OF THE IMAGES PROVIDED OF THE DEVICE TIP DID OBSERVE A SMALL BURN MARK ON THE EFFECTOR SURFACE. THE TIP HAS BEEN RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. AT THIS TIME, IT IS UNKNOWN WHAT CONTRIBUTED TO THE REPORTED MALFUNCTION AND BURNING OBSERVED DAMAGE TO THE TIP OBSERVED IN THE PROVIDED IMAGE. IT IS UNKNOWN WHAT CAUSED THIS OBSERVED DEFECT TO THE TIP. THE DEFECT WAS OBSERVED BUT UNABLE TO BE VERIFIED IF IT CONTRIBUTED TO THE REPORTED BURNING. A FINAL MDR WILL BE SUBMITTED ONCE INVESTIGATION HAS BEEN COMPLETED. SINCE A REPORTED MALFUNCTION AND POTENTIAL FOR SERIOUS INJURY OCCURRED, WE ARE REPORTING THIS AS AN INITIAL MDR.

  Patient problems: Burn(s)

  MAUDE report 23933675 ↗
• MalfunctionSep 11, 2025Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE CONTROVERSIES EVENT IN (B)(6), A PATIENT RECEIVED BURNS DURING ELECTROCOAGULATION TREATMENT ON THE FACE WITH A XERF DEVICE. REVIEW OF THE TREATMENT PARAMETERS USED WERE FOUND TO BE WITHIN THE RECOMMENDED CLINICAL GUIDELINES. REVIEW OF THE SUPPLIED IMAGE OF THE TIP OBSERVED WHAT APPEARED TO BE A BURN MARK. IT IS UNKNOWN WHAT CAUSED THIS VISUAL DISCREPANCY. IMAGES OF THE PATIENT HAVE BEEN REQUESTED TO REVIEW WITH THE CYNOSURE LUTRONIC MEDICAL DIRECTOR, HOWEVER, DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE REQUESTED IMAGES, NONE HAVE NOT BEEN SUPPLIED AT THIS TIME. AT THIS TIME, IT IS UNKNOWN WHAT CONTRIBUTED TO THE REPORTED MALFUNCTION AND BURNING OBSERVED DAMAGE TO THE TIP OBSERVED IN THE PROVIDED IMAGE. IT IS UNKNOWN WHAT CAUSED THIS OBSERVED DEFECT TO THE TIP. THE DEFECT WAS OBSERVED BUT UNABLE TO BE VERIFIED IF IT CONTRIBUTED TO THE REPORTED BURNING. A FINAL MDR WILL BE SUBMITTED ONCE INVESTIGATION HAS BEEN COMPLETED. SINCE A REPORTED MALFUNCTION AND SERIOUS INJURY OCCURRED, WE ARE REPORTING THIS AS AN INITIAL MDR.

  Patient problems: Burn(s)

  MAUDE report 23027970 ↗
• MalfunctionSep 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CORPORATE TRAINING, A STAFF MEMBER EXPERIENCED A BURN ON THE FACE DURING A XERF RF ELECTROCOAGULATION AND HEMOSTASIS TREATMENT. REVIEW OF THE TREATMENT PARAMETERS USED WERE FOUND TO BE WITHIN THE RECOMMENDED CLINICAL GUIDELINES. IMAGES PROVIDED ON 08/13/2025 WERE REVIEWED AND DISCUSSED WITH CYNOSURE LUTRONIC MEDICAL DIRECTOR. CYNOSURE MEDICAL DIRECTOR STATES, "THE REDNESS OBSERVED IN THE IMAGES SUGGESTS A PARTIAL THICKNESS BURN AND THE PATIENT IS AT RISK FOR SCARRING AND/OR HYPER/HYPOPIGMENTATION." THE MEDICAL DIRECTOR COMPLETED A REVIEW OF THE ADDITIONAL IMAGES SUPPLED BETWEEN 08/14/2025-08/27/2025 AND STATED "IT APPEARS THAT THERE MAY BE A SMALL FULL THICKNESS BURN ON THE LEFT JAWLINE." A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. DURING THIS TIME, THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS INCLUDING FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THE DEVICE WAS FOUND TO BE WORKING TO DEVICE PUBLISHED SPECIFICATIONS. HOWEVER, IMAGES OF THE DEVICE TIP WERE REVIEWED AND OBSERVED A MARK WHICH APPEARS TO BE A BURN MARK. IT IS UNKNOWN WHAT CAUSED THIS VISUAL DISCREPANCY. AT THIS TIME, IT IS UNKNOWN WHAT CONTRIBUTED TO THE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23027965 ↗
• MalfunctionSep 11, 2025Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE CONTROVERSIES EVENT IN (B)(4), A PATIENT RECEIVED BURNS DURING ELECTROCOAGULATION TREATMENT ON THE FACE WITH A XERF DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23026601 ↗
• MalfunctionSep 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CORPORATE TRAINING, A STAFF MEMBER EXPERIENCED A BURN ON THE FACE DURING A XERF RF ELECTROCOAGULATION AND HEMOSTASIS TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23026091 ↗