Simplicity™ IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05415067028976), received between Mar 14, 2019 and Jun 10, 2024 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE ON (B)(6) 2024, THE PROBE WAS OVERHEATING AND PATIENT EXPERIENCED PAIN LOCAL. AS A RESULT, THE PROCEDURE WAS ABORTED..

  Patient problems: Pain

  MAUDE report 19506659 ↗
• InjuryNov 8, 2023Insufficient Heating; Insufficient Heating

  IT WAS REPORTED DURING A PROCEDURE THE GENERATOR INDICATED AN ERROR THAT THE TEMPERATURE WAS RISING TOO SLOWLY. THE CASE WAS ABANDONED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091054 ↗
• InjuryJul 17, 2022Fracture; Fracture

  IT WAS REPORTED THE DEVICE BROKE WHILE THE PHYSICIAN WAS REPOSITIONING IT INSIDE THE PATIENT. THE PIECE THAT BROKE OFF INTO THE PATIENT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15036807 ↗
• InjuryOct 4, 2021Material Separation; Material Separation

  DURING A SACRAL RADIOFREQUENCY ABLATION PROCEDURE, THE PROBE FRACTURED AND SEPARATED IN THE PATIENT. AN 18G NEEDLE WAS USED TO TURN THE BROKEN PROBE AND THE BROKEN PROBE WAS REMOVED. THE PROBE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Foreign Body Embolism

  MAUDE report 12569088 ↗
• MalfunctionJul 12, 2021High impedance; Communication or Transmission Problem; High impedance; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING DETACHED ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149297 ↗
• MalfunctionJun 16, 2021Impedance Problem; Impedance Problem

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS WHICH REVEALED A FRACTURED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007653 ↗
• MalfunctionMay 13, 2021Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DETACHED ELECTRODE FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820459 ↗
• MalfunctionFeb 11, 2021Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING DETACHED ELECTRODES ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314615 ↗
• InjurySep 4, 2020Output Problem; Output Problem

  RELATED MANUFACTURING REF: 2182269-2020-00081 DURING A SIMPLICITY RF PROCEDURE WITH THE PATIENT ON THE TABLE AND PREPPED, AN ERROR MESSAGE WAS NOTED ON PORTS ONE AND TWO WHILE CONNECTED TO THE GENERATOR. AN ATTEMPT TO SWITCH PORT 1 AND 2 INTO PORT 3 WERE UNSUCCESSFUL AS THE ERRORS REMAINED AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493606 ↗
• MalfunctionFeb 20, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, TWO OF THE THREE THERMOCOUPLE MODULES ON THE SIMPLICITY PROBE WERE DETACHED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733334 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DETACHED COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944453 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DETACHED COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944437 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DETACHED COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944425 ↗
• InjuryMar 14, 2019Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  RELATED MANUFACTURER REFERENCE: 2182269-2019-00028. DURING A PROCEDURE, THE PROBES WOULD NOT HEAT TO TEMPERATURE AND THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. CABLES AND SETTINGS WERE CHANGED WITH NO RESOLUTION. A THIRD PROBE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8422703 ↗
• InjuryMar 14, 2019Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  RELATED MANUFACTURER REFERENCE: 2182269-2019-00029. DURING A PROCEDURE, THE PROBES WOULD NOT HEAT TO TEMPERATURE AND THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. CABLES AND SETTINGS WERE CHANGED WITH NO RESOLUTION. A THIRD PROBE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8422700 ↗
• InjuryMar 14, 2019Temperature Problem; Temperature Problem

  DURING A PROCEDURE, THE PROBE WOULD NOT HEAT TO TEMPERATURE AND THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. CABLES AND SETTINGS WERE CHANGED WITH NO RESOLUTION. A SECOND PROBE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422693 ↗