PulseSelect™ PSCC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 496 adverse event reports that list this exact device (DI 00763000617554), received between Aug 13, 2024 and Sep 30, 2026 — classified as 3 deaths, 55 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, 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 25 most recent of 496 reports, 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 ↗
• 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 25511550 ↗
• MalfunctionJun 12, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION, WHEN PREPARING TO CONNECT THE CATHETER TO THE PULSE GENERATOR, THE CATHETER TAIL END WAS OBSERVED TO BE FILLED WITH TRANSPARENT GLUE, AND THE CATHETER COULD NOT BE CONNECTED TO THE PULSE GENERATOR, SO THE PROCEDURE COULD NOT PROCEED NORMALLY. THE CATHETER WAS REPLACED WITH A NEW CATHETER AND THE PROCEDURE CONTINUED, AND THE CASE OUTCOME WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491445 ↗
• MalfunctionJun 12, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PULSE FIELD ABLATION PROCEDURE, AFTER THE CATHETER WAS INTRODUCED, AN ATTEMPT WAS MADE TO CONNECT IT TO THE PULSE GENERATOR, BUT THE CATHETER TAIL END WAS REPORTED TO BE FILLED WITH TRANSPARENT GLUE AND THE CATHETER COULD NOT BE CONNECTED TO THE PULSE GENERATOR, SO THE PROCEDURE COULD NOT PROCEED NORMALLY AND WAS INTERRUPTED. THE CATHETER WAS REPLACED WITH A NEW CATHETER AND THE PROCEDURE CONTINUED. 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 25491406 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE, A CATHETER ARRAY INVERSION OCCURRED. AFTER MAPPING OF THE FOUR PULMONARY VEINS WAS PERFORMED, ADDITIONAL ABLATION WAS PLANNED AT LOCATIONS WHERE POTENTIALS REMAINED, AND THE CATHETER WAS SET UP AGAIN. WHEN THE CATHETER STORED IN THE CAPTURE DEVICE WAS INSERTED INTO THE SHEATH, THE CATHETER COULD NOT BE INSERTED. WHEN THE CAPTURE DEVICE WAS MOVED IN ORDER TO CHECK THE RING CONDITION, THE CAPTURE DEVICE BECAME DETACHED FROM THE SHAFT. THE DETACHED CAPTURE DEVICE WAS REATTACHED FROM THE CATHETER TIP, AND AFTER CONFIRMING THAT RING DEPLOYMENT HAD NO ISSUE, IT WAS INSERTED INTO THE BODY AGAIN. WHEN DEPLOYED IN THE LEFT ATRIUM, THE RING DID NOT DEPLOY PROPERLY, AND THE CATHETER WAS REPLACED WITH ANOTHER CATHETER. 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 25472902 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WAS EXCESSIVE INTERFERENCE WITH THE ELECTRICAL POTENTIALS, MAKING THE SIGNALS DIFFICULT TO VISUALIZE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED BEFORE BEING ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429407 ↗
• MalfunctionMay 29, 2026Thermal Decomposition of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE CATHETER PSCC100 PULSESELECT, AN ALLEGED PRODUCT ISSUE OCCURRED INVOLVING A CABLE CONNECTION PROBLEM. ERROR 4002 WAS EXPERIENCED DURING THE CONNECTION OF THE FIRST CATHETER, AND DISCONNECTING AND RECONNECTING THE CIC CABLE CLEARED THE ERROR MESSAGE. HOWEVER, ONCE THE CATHETER WAS PLACED IN THE PATIENT'S HEART, SIGNALS FROM THE CATHETER COULD NOT BE OBSERVED PROPERLY AS THEY WERE SATURATED. CHANGING THE CIC CABLE DID NOT RESOLVE THE SIGNAL ISSUE, SO THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE SECOND CATHETER WAS SUCCESSFUL, AND AT THE END OF THE CASE, BOTH CATHETERS WERE COLLECTED FOR INVESTIGATION. THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PROCEDURE WAS COMPLETED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND NO INJURY OR COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333889 ↗
• MalfunctionMay 29, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WAS A CABLE CONNECTION ISSUE, AND NOISE ON THE RECORDING SYSTEM. THE EVENT WAS DESCRIBED AS A VISUAL PROBLEM THAT IMPEDED THE SPEED AND VISIBILITY OF DATA DURING THE CASE. 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 25333753 ↗
• MalfunctionMay 29, 2026Thermal Decomposition of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE CATHETER PSCC100 PULSESELECT, AN ALLEGED PRODUCT ISSUE OCCURRED INVOLVING A CABLE CONNECTION PROBLEM. ERROR 4002 WAS EXPERIENCED DURING THE CONNECTION OF THE FIRST CATHETER, AND DISCONNECTING AND RECONNECTING THE CIC CABLE CLEARED THE ERROR MESSAGE. HOWEVER, ONCE THE CATHETER WAS PLACED IN THE PATIENT'S HEART, SIGNALS FROM THE CATHETER COULD NOT BE OBSERVED PROPERLY AS THEY WERE SATURATED. CHANGING THE CIC CABLE DID NOT RESOLVE THE SIGNAL ISSUE, SO THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE SECOND CATHETER WAS SUCCESSFUL, AND AT THE END OF THE CASE, BOTH CATHETERS WERE COLLECTED FOR INVESTIGATION. THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PROCEDURE WAS COMPLETED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND NO INJURY OR COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333142 ↗
• MalfunctionMay 29, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, PULSESELECT PULSED FIELD ABLATION LOOP CATHETER EXPERIENCED ARRAY INVERSION. THIS CATHETER WAS REPLACED TO RESOLVE ISSUE. THE REPLACEMENT CATHETER EXPERIENCED AN INVALID CATHETER ERROR AND CONNECTION ISSUE. THE CATHETER INTERFACE CABLE ALSO EXPERIENCED CABLE CONNECTION ISSUES AS A RESULT OF THE INVALID ERROR. THIS CATHETER AND CATHETER INTERFACE CABLE (CIC) WERE REPLACED AND ISSUE WAS RESOLVED. 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 25332619 ↗
• MalfunctionMay 28, 2026Material Deformation

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE FOR A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, THE PULSESELECT CATHETER EXHIBITED A NOISY ELECTROGRAM AND APPEARED DISTORTED ON THE MAPPING SYSTEM. TWICE DURING THE CASE, NOISE WAS OBSERVED ON PULSESELECT ELECTROGRAM 8-9, AND THE CATHETER APPEARED DISTORTED ON THE ENSITE MAP. A CABLE CONNECTION ISSUE WAS IDENTIFIED, AS THE CIC APPEARED TO HAVE A LOOSENED CONNECTION EVEN WHEN TIGHTLY SECURED TO THE PULSESELECT CATHETER. THE CIC WAS PUSHED IN TIGHTLY, WHICH RESOLVED THE NOISE. THE CASE WAS COMPLETED SUCCESSFULLY UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, INJURIES, OR EXTENDED HOSPITALIZATION RELATED TO THE EVENT. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317080 ↗