Maestro Foot Switch M004218500Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729862437), received between Aug 29, 2017 and Oct 4, 2022 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (21 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Device Remains Activated; Device Remains Activated

  DURING A PROCEDURE, A MAESTRO 4000 GENERATOR WITH FOOTSWITCH WAS SELECTED FOR USE. IT WAS REPORTED THAT SOMETIMES THE FOOTSWITCH DID NOT HALT ABLATION WHEN STEPPED ON. THE PROCEDURE WAS COMPLETED AFTER DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540216 ↗
• MalfunctionAug 27, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A MAESTRO FOOT SWITCH WAS USED IN A ABLATION PROCEDURE. WHEN THE FOOT PEDAL WAS USED NO RESPONSE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER FOOT PEDAL WAS USED WITH NO PATIENT COMPLICATIONS BEING REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459511 ↗
• MalfunctionJan 31, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT RADIOFREQUENCY (RF) ABLATION WAS NOT HALTED AFTER THE PHYSICIAN REMOVED HIS FOOT FROM THE FOOT SWITCH. DURING A SLOW PATHWAY ATRIOVENTRICULAR (AV) NODE MODIFICATION ABLATION PROCEDURE TO TREAT AV-NODAL REENTRANT TACHYCARDIA A MAESTRO 4000 SYSTEM WAS USED. THE PHYSICIAN PROCEEDED TO ABLATE USING THE FOOT SWITCH, AFTER SUCCESSFULLY COMPLETING THE FIRST ABLATION LESION, WHEN HE REMOVED HIS FOOT FROM THE FOOT SWITCH, RF ENERGY CONTINUED TO BE DELIVERED TO THE PATIENT. THE ABLATION CATHETER WAS PULLED INTO THE SHEATH AND AWAY FROM THE TREATMENT AREA. THE FOOT SWITCH WAS DISCONNECTED AND THE PROCEDURE WAS COMPLETED BY CONTROLLING THE ABLATION VIA THE ON/OFF SWITCH ON THE MAESTRO GENERATOR. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

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

  MAUDE report 9652808 ↗
• MalfunctionDec 19, 2019Device Remains Activated; Defective Device; Device Remains Activated; Defective Device

  IT WAS REPORTED THAT ABLATION COULD NOT BE HALTED. DURING AN ABLATION PROCEDURE, THE GENERATOR WAS ENERGIZED WITH THE MAESTRO FOOT SWITCH, BUT ABLATION WAS UNABLE TO BE TURNED OFF. NO SERIOUS INJURIES OR ADVERSE PATIENT EFFECTS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9495178 ↗
• MalfunctionDec 12, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE MAESTRO 4000 FOOT SWITCH FAILED TO HALT RADIOFREQUENCY (RF) DELIVERY. DURING AN ABLATION PROCEDURE FOR TYPICAL ATRIAL FLUTTER, THE MAESTRO 4000 GENERATOR DID NOT STOP DELIVERING POWER WHEN FOOT PEDAL WAS RELEASED. THE FOOT PEDAL WAS STEPPED ON AGAIN, BUT DIDN'T HAVE AN EFFECT. IT ONLY STOPPED WHEN THE BUTTON WAS PUSHED ON THE GENERATOR ITSELF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460204 ↗
• MalfunctionNov 12, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOTSWITCH COULD NOT HALT ABLATION. DURING A MYOCARDIAL ABLATION PROCEDURE, THE MAESTRO 4000 FOOTSWITCH STOPPED WORKING AFTER SEVERAL ABLATIONS, AND ENERGIZATION COULD NOT BE TURNED OFF. THE PHYSICIAN NEEDED TO STEP ON THE FOOTSWITCH AGAIN TO TURN OFF ABLATION. THE FOOTSWITCH CONTINUED TO BE USED, BUT THE ISSUE DID NOT REOCCUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO SERIOUS INJURIES OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309655 ↗
• MalfunctionNov 12, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOT SWITCH WOULD NOT STOP ABLATION. DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE, THE PHYSICIAN WAS DOING AN ABLATION USING THE MAESTRO 4000 FOOTSWITCH, WHEN THE PHYSICIAN'S FOOT WAS LIFTED TO COME OFF ABLATION, IT THE MAESTRO 4000 CONTINUED TO ABLATE. ABLATION WAS STOPPED BY SWITCHING IT OFF ON THE MACHINE. THERE WERE NOT PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309532 ↗
• MalfunctionOct 23, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN THE PHYSICIAN CAME OFF ABLATION WITH THE FOOT PEDAL, THE MAESTRO 4000 GENERATOR CONTINUED TO DELIVER RADIOFREQUENCY (RF). DURING AN ABLATION PROCEDURE, THE PHYSICIAN CAME OFF ABLATION WITH THE FOOT PEDAL AND THE GENERATOR CONTINUED TO DELIVER RF. THEY HIT THE RF BUTTON ON THE REMOTE CONTROL TO TERMINATE RF. NO PATIENT INJURY OCCURRED. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO OTHER ISSUES. THE GENERATOR HAS BEEN UPGRADED WITH THE NEW FIRMWARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226571 ↗
• MalfunctionSep 10, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE WAS A FAILURE TO HALT RADIO FREQUENCY (RF) ABLATION. DURING AN ABLATION PROCEDURE, WHEN THE PHYSICIAN CAME OFF ABLATION WITH THE MAESTRO FOOT SWITCH, THE GENERATOR CONTINUED TO DELIVER RF AND CONTINUED MAKING THE SOUND OF RF. THE PHYSICIAN DOUBLE TAPPED THE FOOT PEDAL TO COME OFF ABLATION. NO PATIENT INJURY OCCURRED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO OTHER ISSUES. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS TO TREAT ATRIAL FIBRILLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982654 ↗
• MalfunctionAug 1, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT LIFTING THE FOOT PEDAL DID NOT HALT ABLATION. DURING AN ABLATION PROCEDURE, THE FOOT PEDAL FOR THE MAESTRO GENERATOR WAS NOT FUNCTIONING. WHEN THE FOOT WAS LIFTED TO COME OFF ABLATION, THE GENERATOR DID NOT TURN OFF AND RADIOFREQUENCY (RF) ABLATION WAS NOT HALTED. THE ABLATION CATHETER WAS DISCONNECTED FROM THE POD TO STOP ABLATION. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851788 ↗
• MalfunctionMay 28, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOTSWITCH STUCK. IT WAS REPORTED THAT THE MAESTRO 4000 FOOTSWITCH WAS "STICKING". THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646837 ↗
• MalfunctionFeb 14, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOT PEDAL WAS STICKING. A MAESTRO 4000 FOOTSWITCH WAS SELECTED FOR A ABLATION PROCEDURE. HOWEVER IT WAS NOTED THAT THE FOOT SWITCH WAS STICKING COMING OUT OF ABLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338751 ↗
• MalfunctionJan 30, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT FOOTSWITCH FAILED TO HALT ABLATION. IT WAS REPORTED THAT DURING ABLATION THE MAESTRO 4000 FOOTSWITCH STUCK AND THE ABLATION HAD TO BE MANUALLY TURNED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME MAESTRO AND FOOT PEDAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289533 ↗
• MalfunctionJul 11, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT RF ENERGY CONTINUED WHEN THE FOOTSWITCH WAS RELEASED. A MAESTRO 4000 FOOT SWITCH WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE MAESTRO WOULD NOT STOP DELIVERING RF ENERGY EVEN IF FOOT PEDAL WAS NO LONGER PUSHED. THE RF CONTROL BUTTON ON THE REMOTE WAS PRESSED AND THE GENERATOR WAS SHUT OFF. THE PROCEDURE WAS COMPLETED USING THE SAME GENERATOR. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677722 ↗
• MalfunctionJun 29, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO HALT ABLATION. A MAESTRO FOOT SWITCH WAS USED IN A TRIOVENTRICULAR REENTRANT TACHYCARDIA ABLATION. HOWEVER DURING ABLATION THE PHYSICIAN TRIED END THE ABLATION USING MAESTRO FOOT SWITCH BUT ABLATION DID NOT STOP. ABLATION WAS THEN STOPPED MANUALLY WHICH LED TO 4SEC LONGER ABLATION THEN PLANNED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650660 ↗
• MalfunctionMar 14, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOT SWITCH FAILED TO HALT RF DELIVERY. DURING AN ATRIOVENTRICULAR NODE REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE, THE PHYSICIAN WAS ABLATING AND LIFTED HIS FOOT OFF MAESTRO FOOT SWITCH; HOWEVER, ABLATION DID NOT STOP. ABLATION WAS TURNED OFF MANUALLY USING THE REMOTE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337327 ↗
• MalfunctionDec 7, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED RF ENERGY CONTINUED WHEN THE FOOTSWITCH WAS RELEASED. DURING PROCEDURE, IT WAS NOTED THAT WHEN THE MAESTRO FOOTSWITCH WAS RELEASED RF DELIVERY DID NOT STOP. THE RF GENERATOR WAS THEN UNPLUGGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7095168 ↗
• MalfunctionDec 5, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED RF ENERGY CONTINUED WHEN THE FOOTSWITCH WAS RELEASED. THE MAESTRO FOOTSWITCH WAS ¿STICKING¿ WHEN COMING OFF ABLATION; POWER CONTINUED TO FLOW AFTER PRESSURE WAS LIFTED OFF THE FOOTSWITCH. THE FOOTSWITCH WAS UNPLUGGED AND THE PROCEDURE WAS CONTINUED USING THE BUTTON ON THE GENERATOR. THE ISSUE DID NOT OCCUR WHEN THE FOOTSWITCH WAS NOT IN USE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083086 ↗
• MalfunctionNov 20, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A DEVICE DEACTIVATION ISSUE OCCURRED. A MAESTRO FOOT SWITCH WAS SELECTED FOR USE. MAESTRO CONTROLLER WAS ALSO USED TOGETHER WITH THIS DEVICE. HOWEVER, DURING THE PROCEDURE, THE MAESTRO SYSTEM DID NOT STOP ABLATION AFTER FOOTSWITCH WAS RELEASED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7045802 ↗
• MalfunctionNov 9, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOTSWITCH CANNOT DEACTIVATE RF DELIVERY. A MAESTRO FOOT SWITCH AND A MAESTRO 4000¿ CONTROLLER WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MAESTRO WOULD NOT STOP ABLATING EVEN WHEN THE FOOT PEDAL WAS PRESSED. THE POWER CONTROL BUTTON ON THE CONTROLLER WAS NOT USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7013495 ↗
• MalfunctionOct 31, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A DEVICE DEACTIVATION ISSUE OCCURRED. A MAESTRO FOOT SWITCH FAILED TO DEACTIVATE EVEN AFTER USE. THE CONSOLE NEEDED TO BE SHUT DOWN IN ORDER TO DEACTIVATE THE DEVICE. THERE WAS NO PATIENT INVOLVED DURING THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6990672 ↗
• MalfunctionOct 26, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOTSWITCH CANNOT DEACTIVATE RF DELIVERY. THE TARGET LESION WAS LOCATED IN THE FLOOR OF THE RIGHT ATRIUM. A MAESTRO FOOT SWITCH AND A MAESTRO 4000¿ CONTROLLER WERE SELECTED FOR USE. DURING THE PROCEDURE, A SUCCESSFUL TYPICAL FLUTTER CTI ABLATION USING A MAESTRO 4000 AND A FOOT PEDAL, ALONG WITH A MIFI NAV XP AND A RHYTHMIA SYSTEM WAS PERFORMED. AFTER APPROXIMATELY 30 LESION, PHYSICIAN STEPPED OFF THE DEVICE. HOWEVER, RF ENERGY CONTINUED TO DELIVER. IT WAS STOPPED BY SHUTTING DOWN THE GENERATOR REMOTELY. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980419 ↗
• MalfunctionAug 29, 2017Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THE FOOT SWITCH DID NOT DEACTIVATE RF DELIVERY. DURING AN ABLATION PROCEDURE TO TREAT INTRANODAL TACHYCARDIA, THE MAESTRO FOOT SWITCH ¿BLOCKED¿ AND COULD NOT STOP EMITTING RADIOFREQUENCY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THAT PATIENT WAS IN ¿GOOD¿ CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826484 ↗