PulseSelect™ PSG100Recalls & reported problems
Medtronic, Inc. · GENERATOR PSG100 PULSESELECT US · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000617530), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRIOR TO A PULSED FIELD ABLATION PROCEDURE, AN ERROR MESSAGE WAS RECEIVED INDICATING THAT THERE WAS AN EMBEDDED POWER-ON-SELF-TEST (POST) FAILURE. THE FAILURE WAS VERIFIED AND NOT RESOLVED. MULTIPLE TROUBLESHOOTING STEPS WERE ATTEMPTED, INCLUDING REBOOTING THE DEVICE SEVERAL TIMES AND REBOOTING WITHOUT THE CABLES ATTACHED, BUT NO RESOLUTION WAS FOUND. THE UNIT WAS ONSITE FOR EVALUATION. TECHNICAL SERVICES RECOMMENDED REPLACEMENT OF THE EVALUATION UNIT AND DEPOT REPAIR OF THE BROKEN UNIT. A BACKUP DEVICE WAS USED. DESPITE THIS, THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292350 ↗
Other Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation devices
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- FARAWAVE™ NAV M004PF41M411Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- VARIPULSE™ Bi-Directional Catheter D141201Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
- FARAWAVE™ M004PF41M431Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall15 reports
- FARAWAVE™ M004PF41M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- Volt™ PFA Sensor Enabled™ A-VOLT-01St. Jude Medical, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths38 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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