PulseSelectRecalls & reported problems across all models

We found 2 models of PulseSelect by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 497 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2024 and Sep 30, 2026 — classified as 3 deaths, 56 injuries, 438 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (220 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PulseSelect problems

PulseSelect models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PulseSelect™ PSCC100

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  3 deaths496 reports
• PulseSelect™ PSG100

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  1 report

Recent PulseSelect adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  It was reported that prior to a cardiac ablation procedure, the catheter tip was observed to be deformed prior to insertion. The catheter was deployed into the heart, but during the procedure, the catheter was again deformed and it was inverted. The catheter was replaced, which resolved the issue. The case was completed with Pulsed Field Ablation. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946343 ↗
• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884064 ↗
• MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829539 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Pulsed Field Ablation procedure, typical atrial flutter occurred. After ablation with the Pulse Select catheter, the potentials were still present. Additional ablation was then performed using a competitior's catheter. Radiofrequency ablation was required to resolve the atrial flutter. The case was completed. No further patient complications have been reported asa result of this event.

  Patient problems: Atrial Flutter

  MAUDE report 50829292 ↗
• MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791503 ↗
• MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735117 ↗
• MalfunctionSep 11, 2026Material Twisted/Bent

  It was reported that during a Pulsed Field Ablation procedure, a catheter kink was observed. The catheter was replaced which resolved the issue. The case was completed with Pulsed Field Ablation. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729831 ↗
• InjurySep 9, 2026Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure, during guidewire advancement toward the left superior pulmonary vein, fluo roscopy showed a foreign object emerging near the sheath tip. The physician withdrew the system, and the foreign object retracted into the sheath; upon a subsequent guidewire advancement attempt, the foreign object reappeared. A foreign object was alleged to have been introduced inside the sheath, and with uncertainty whether it originated from the catheter or from material shaved within another sheath or introducer. A foreign object was also reported inside the catheter and was drawn out by the guidewire while it was being positioned. No resistance was encountered during advancement through the sheath. Intracardiac echocardiography reportedly visualized the foreign object during the procedure. The case was aborted the patient was under general anesthesia. No further patient complications have been reported as a result of this event.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50692859 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Speech Disorder

  MAUDE report 50679680 ↗
• MalfunctionSep 8, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674923 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  It was reported that once the catheter entered the patients body, noisy electrograms were observed. The cable was reconnected and catheter interface cable was replaced without resolution. The catheter was replaced which resolved the issue. The case was completed. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667804 ↗
• MalfunctionAug 20, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354303 ↗
• MalfunctionAug 12, 2026Off-Label Use; Material Deformation

  It was reported that during a Pulsed Field Ablation procedure, the catheter became tied in a knot. The catheter was untied and returned to its loop shape. Electrodes 1 and 2 exhibited noisy, non-diagnostic signals. Post-ablation mapping showed effective ablation despite the catheter incident. The procedure was completed. It was noted that the catheter and catheter interface cable (CIC) were expired during use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226055 ↗
• MalfunctionJun 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE LOOP CATHETER COULD NOT BE CONNECTED BECAUSE THE CATHETER TAIL END WAS FILLED WITH TRANSPARENT ADHESIVE/GLUE, AND THE PROCEDURE COULD NOT PROCEED NORMALLY. THE CASE WAS STITCHED TO AND COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516939 ↗
• MalfunctionJun 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PULSE FIELD CARDIAC ABLATION PROCEDURE, AFTER ASSEMBLING THE CATHETER AND CONNECTED TO THE CATHETER INTERFACE CABLE (CIC), THE CABLE COULD NOT BE PROPERLY CONNECTED, THE CATHETER COULD NOT BE FULLY INSERTED, AND MULTIPLE CHANNELS DID NOT DISPLAY SIGNALS. IT WAS REPORTED THAT THERE WAS A LARGE AMOUNT OF GLUE RESIDUE AT THE CATHETER TAIL CABLE INTERFACE AND ASSESSED THAT THE CATHETER NEEDED TO BE REPLACED TO PROCEED WITH ABLATION. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER; AFTER STANDARD ASSEMBLY AND ATTEMPTED CABLE CONNECTION, THE SAME ISSUES WERE REPORTED, INCLUDING INABILITY TO PROPERLY CONNECT THE CABLE, INABILITY TO FULLY INSERT THE CATHETER, MULTIPLE CHANNELS NOT DISPLAYING SIGNALS, AND A LARGE AMOUNT OF GLUE RESIDUE AT THE CATHETER TAIL CABLE INTERFACE. THE CATHETER WAS REPLACED AGAIN AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511560 ↗

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