Baylis Medical Company Radiofrequency Puncture Generator RFP-100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00685447000969), received between Mar 1, 2021 and Jun 17, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A RADIOFREQUENCY PUNCTURE GENERATOR WAS USED TO PERFORM A TRANSEPTAL PUNCTURE. AT AN UNSPECIFIED TIME DURING THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE. A PERICARDIAL EFFUSION WAS SUSPECTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER TO A HOSPITAL AND SUBSEQUENTLY DISCHARGED ON AN UNREPORTED DATE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25536368 ↗
• MalfunctionNov 14, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT A BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR IS PRESENTING AN ISSUE. IT WAS FOUND THAT WHEN THE RADIOFREQUENCY BUTTON WAS PRESSED, THERE WAS A DELAY BEFORE THE RF ENERGY COMES ON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556173 ↗
• MalfunctionAug 14, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A BMC RF PUNCTURE GENERATOR AND VERSACROSS LARGE ACCESS KIT WERE SELECTED FOR USE. WHEN THE RADIO FREQUENCY (RF) WAS DELIVERED BY THE GENERATOR, THE LAB STAFF NOTED THAT THE GENERATOR DID NOT STOP AFTER PROGRAMMED 1 (ONE) SECOND RF. THE GROUND CABLE WAS PULLED OUT IN ORDER TO STOP THE RF DELIVERY. AN ALTERNATIVE GENERATOR WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE BMC RF GENERATOR WAS USED LATER ON AND NO ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982181 ↗
• MalfunctionJun 26, 2024Therapy Delivered to Incorrect Body Area; Device Displays Incorrect Message; Therapy Delivered to Incorrect Body Area; Device Displays Incorrect Message

  IT WAS REPORTED THAT A BMC RF PUNCTURE GENERATOR SELECTED FOR USE, EVEN WHEN THE FOOT SWITCH WAS NOT PRESSED, GET TO HAVE THE NEEDLE ENERGIZED. ALSO, IT WAS NOTED THAT AN ERROR CODE WAS GIVEN TWICE AFTER THE POWER WAS TURNED ON REGARDLESS OF NOT PRESSING THE FOOT SWITCH. NO DISTURBANCE TO THE MAIN POWER NOR ANY DAMAGE OR ANY OTHER ALERT/ERROR WAS OBSERVED. NO OTHER INFORMATION WAS DISCLOSED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617946 ↗
• MalfunctionMay 15, 2024Defective Device; Device Displays Incorrect Message; Connection Problem; Defective Device; Device Displays Incorrect Message; Connection Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE. IT HAS BEEN REPORTED THAT AN BMC RF PUNCTURE GENERATOR WAS SELECTED FOR USE. IT WAS REPORTED THAT WHEN A NON-BOSTON SCIENTIFIC WIRE WAS ATTACHED TO THE NON-BOSTON SCIENTIFIC GROUNDING PADS, THE BMC GENERATOR GAVE AN ERROR. IT DID NOT RECOGNIZE THE GROUNDING PADS. THUS, MULTIPLE PADS WERE TRIED AT DIFFERENT SPOTS ON THE PATIENT'S BODY, BUT THE ISSUES PERSISTED. THE NON-BOSTON SCIENTIFIC GROUNDING PAD WOULD NOT BE CONNECTED. THEREFORE, THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325787 ↗
• MalfunctionJul 18, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A BMC RF PUNCTURE GENERATOR WAS SELECTED FOR USE DURING A PORTAL VEIN RE-CANNILAZATION PROCEDURE, AND ONCE CONNECTED TO THE CONNECTOR CABLES AND A NON-BOSTON SCIENTIFIC WIRE THE CONSOLE GAVE THE ALERT A029. THE GROUNDING PAD WAS CONNECTED AND NO ERROR WAS GIVEN. HOWEVER, ONCE THE DEVICES WERE CONNECTED TO THE GENERATOR ALONG WITH THE CONNECTOR CABLE, AGAIN THE ERROR WAS DISPLAYED. TO TROUBLESHOOT, THE BMC GENERATOR WAS TURNED OFF AND BACK ON AFTER THE MESSAGE. ALSO, THE CONNECTOR CABLES FOR TWO NON-BOSTON SCIENTIFIC WIRES WERE UNPLUGGED AND PLUGGED BACK IN AND THE ERROR PERSISTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS ABORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343218 ↗
• MalfunctionFeb 10, 2023Sparking; Sparking

  DURING THE PROCEDURE, THE PHYSICIAN WITNESSED SPARKS RELATED TO THE BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR. THE GENERATOR CEASED OPERATION LEADING TO A 20-MINUTE PROCEDURAL DELAY. AS A RESULT, A MECHANICAL NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT OR USER. WHILE THERE WAS NO PATIENT OR USER INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE MALFUNCTION OF THE BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358174 ↗
• MalfunctionFeb 7, 2023Failure to Deliver Energy; Failure to Deliver Energy

  A 20- MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR THE PROCEDURE. DURING A CARDIOLOGY PROCEDURE, THE RF GENERATOR WAS CONNECTED TO A COMPATIBLE RADIOFREQUENCY (RF) PUNCTURE DEVICE. RF WAS ATTEMPTED, HOWEVER THE GENERATOR WOULD NOT PRODUCE RF. THE GENERATOR WAS RESTARTED, AND A NEW COMPATIBLE DEVICE WAS CONNECTED HOWEVER THIS DID NOT RESOLVE THE ISSUE. AN ALTERNATE BAYLIS RF GENERATOR WAS SETUP AND USED FOR SUCCESSFUL RF DELIVERY. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315188 ↗
• MalfunctionDec 13, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A 20- MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR A TRANSSEPTAL PROCEDURE. DURING A CARDIOLOGY PROCEDURE, THE RF GENERATOR WAS ATTEMPTED TO BE USED TO PROVIDE RF ENERGY TO THE TRANSSEPTAL DEVICE. A 20-MINUTE PROCEDURAL DELAY DUE TO ISSUES WITH A BUTTON ON THE GENERATOR WAS REPORTED AND AN ALTERNATE METHOD FOR TRANSSEPTAL PUNCTURE WAS USED FOR THE PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974238 ↗
• MalfunctionDec 13, 2022No Apparent Adverse Event; Key or Button Unresponsive/not Working; No Apparent Adverse Event; Key or Button Unresponsive/not Working

  A PROCEDURAL ABORTION WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR A TRANSSEPTAL PROCEDURE. PRIOR TO THE START OF THE PROCEDURE THE RF GENERATOR WAS CONNECTED, AND AN ERROR WAS PRODUCED. THE GENERATOR WAS RESTARTED, HOWEVER THE ERROR PERSISTED. ANOTHER MEANS OF TRANSSEPTAL WAS NOT CONSIDERED AND THE PROCEDURE WAS ABORTED. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969102 ↗
• MalfunctionAug 24, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A PROCEDURAL ABORTION WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR A TRANSSEPTAL PROCEDURE. THE RF GENERATOR PRODUCED AN ERROR AND WAS UNABLE TO REBOOT. NO OTHER RF GENERATOR WAS AVAILABLE FOR THE PROCEDURE. ANOTHER MEANS OF TRANSSEPTAL WAS NOT CONSIDERED AND THE PROCEDURE WAS ABORTED. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285178 ↗
• MalfunctionAug 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A PROCEDURAL ABORTION WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR A TRANSSEPTAL PROCEDURE. WHILE SETTING UP FOR THE PROCEDURE, THE RF GENERATOR WAS NOT ABLE TO RECOGNIZE THE DISPERSIVE ELECTRODE GROUNDING PAD. OTHER DISPERSIVE ELECTRODES WERE ATTEMPTED TO BE USED WITHOUT SUCCESS. ANOTHER MEANS OF TRANSSEPTAL WAS NOT CONSIDERED AND THE PROCEDURE WAS ABORTED. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246779 ↗
• MalfunctionJun 23, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A 25-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR PRODUCED AN ERROR AND FAILED TO DELIVER RF ENERGY. AFTER THE FIRST FAILED ATTEMPT, THE RF DEVICES WERE DISCONNECTED AND RECONNECTED. A SECOND ATTEMPT WAS MADE TO DELIVER RF ENERGY, BUT THE ERROR CODE OCCURRED AGAIN. A MECHANICAL DEVICE USED FOR THE TRANSSEPTAL PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14794442 ↗
• MalfunctionAug 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A 20-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR WAS NOT RECOGNIZING THE GROUNDING PAD. THE ISSUE WAS RESOLVED WHEN ANOTHER GENERATOR WAS USED FOR THE PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12367885 ↗
• MalfunctionAug 5, 2021Failure to Power Up; Failure to Power Up

  A 20-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR PRODUCED AN ERROR AND WAS UNABLE TO REBOOT. ANOTHER GENERATOR WAS USED FOR THE PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278842 ↗
• MalfunctionMar 1, 2021Impedance Problem; Impedance Problem

  THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR SHOWED AN IMPEDANCE ERROR CODE WHEN THE NRG TRANSSEPTAL NEEDLE WAS USED TO ATTEMPT RF DELIVERY, RESULTING IN A 60-MINUTE DELAY IN THE PROCEDURE. THE NEEDLE, CONNECTOR CABLE AND GROUNDING PAD WERE EXCHANGED FOR DIFFERENT ONES, HOWEVER THE GENERATOR CONTINUED TO SHOW THE SAME ERROR CODE. THE TRANSSEPTAL PUNCTURE WAS ACHIEVED SUCCESSFULLY WITHOUT THE USE OF RADIOFREQUENCY ENERGY. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY OF 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396675 ↗