FlexCath Contour™ 10FCC13Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00763000659080), received between Mar 5, 2024 and Sep 21, 2026 — classified as 2 deaths, 32 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (60 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Gas/Air Leak; Material Integrity Problem

  It was reported that prior to a pulse field ablation procedure, the slide control of the catheter could not be pushed in more than halfway and resistance was noted. The catheter was replaced which resolved the issue. It was also noted that when  inserting the catheter, air was vented from the side port of the sheath, but the error did not clear completely. Because air was coming from the valve side of the sheath, a valve malfunction was suspected, so the sheath was replaced. 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 50840485 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE, AFTER TWO PULSE TRAINS, THE PATIENT EXPERIENCED VIOLENT COUGHING, WHICH REQUIRED CONVERSION TO GENERAL ANESTHESIA. WHEN PULSE FIELD ABLATION (PFA) WAS ATTEMPTED, THE PATIENT DEVELOPED VERY LOW BLOOD PRESSURE. IT WAS THEN INTERVENED AND TREATED. THE LEFT-SIDED ABLATION WAS ABANDONED, AND THEY PROCEEDED WITH RIGHT-SIDED FLUTTER ABLATION USING ANOTHER COMPANY'S CATHETER. IT WAS LATER REPORTED THAT THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MANUFACTURER'S RADIOFREQUENCY (RF) CATHETER WITH MONITORED ANESTHESIA CARE (MAC). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cough; Low Blood Pressure/ Hypotension

  MAUDE report 24871173 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT, DURING USE OF THE FLEXCATH CONTOUR SHEATH AND THE AFFERA IMPEDANCE MAPPING SYSTEM DURING A CARDIAC ABLATION PROCEDURE, THE SHEATH SIDE PORT WAS KINKED AND AN AIR BUBBLE WAS NOTED IN THE AREA OF THE SIDE PORT AT THE END OF THE PROCEDURE. AN ATTEMPT WAS MADE TO ASPIRATE AND FLUSH VIA THE SIDE PORT BUT WAS UNABLE TO CLEAR THE AIR BUBBLE, AND CONTINUED SHEATH USAGE WAS REPORTED. DURING USE OF THE SYSTEM, A NOISY ELECTROGRAM WAS REPORTED ALONG WITH ERROR MESSAGES INCLUDING PULSED FIELD GENERATOR (PFG) TO RADIOFREQUENCY GENERATOR (RFG) COMMUNICATION ERROR, AN INTERNAL SOFTWARE ERROR, PATCH KEY READ FAIL ERROR. 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 24780382 ↗
• MalfunctionMar 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, ANOTHER MANUFACTURER'S GUIDEWIRE APPEARED KINKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND DIFFICULT TO MANIPULATE. THE SPHERE 360 CATHETER WAS REMOVED AND THE GUIDEWIRE WAS REPLACED. IT WAS NOTED THAT AS THE CATHETER WAS BEING INSERTED INTO THE SHEATH, "FILAMENT" LIKE STRING FROM THE VALVE AREA WAS OBSERVED. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THERE WAS ALSO AN ISSUE WITH THE PRISM 2 AFFERA SYSTEM IN WHICH THREE CHANNELS (1-2, 5-6, 9-10) COULD NOT BE VISUALIZED ON THE RECORDING SYSTEM. THESE CHANNELS COLLECT MAPPING INFORMATION AND CAN BE VISUALIZED ON AFFERA. PACING FROM BOTH AFFERA AND THE RECORDING SYSTEM REMAINS UNAFFECTED. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663691 ↗
• MalfunctionMar 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, ANOTHER MANUFACTURER'S GUIDEWIRE BECAME DIFFICULT TO MANIPULATE. THE CATHETER WAS REMOVED, AND THE DISTAL PORTION OF THE GUIDEWIRE WAS FOUND TO BE BENT AND DEFORMED. THE GUIDEWIRE WAS REPLACED, AND NO FURTHER ISSUES WERE NOTED. THE PHYSICIAN NOTICED A FILAMENT-LIKE STRING WHEN PREPARING TO REINSERT THE CATHETER INTO THE SHEATH, LEADING TO REPLACEMENT OF THE SHEATH WHICH RESOLVED THE ISSUE. ADDITIONALLY, AN ISSUE WITH THE PRISM 2 AFFERA SYSTEM WAS NOTED, WHERE THREECHANNELS (1-2, 5-6, 9-10) COULD NOT BE VISUALIZED ON THE RECORDING SYSTEM, THOUGH MAPPING INFORMATION WAS STILL COLLECTED AND PACING REMAINED UNAFFECTED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654213 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A CORONARY SPASM WAS OBSERVED AND REQUIRED ADMINISTRATION OF A VASODILATOR. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vasospasm

  MAUDE report 24598860 ↗
• MalfunctionMar 6, 2026Device Contamination with Chemical or Other Material

  IT WAS LATER REPORTED THAT ONCE THE OBJECT WAS REMOVED THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531629 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, ST ELEVATION WAS OBSERVED IN THE V1/V2 LEADS WHEN ATTEMPTING TO REMOVE THE SHEATH. A VASODILATOR WAS ADMINISTERED INTRAVENOUSLY. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24484918 ↗
• MalfunctionFeb 26, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE CATHETER REQUIRED INCREASING EXCESSIVE FORCE FOR REMOVAL FROM THE SHEATH. THE ARRAY WAS NOT RECAPTURED WITH THE CAPTURE TOOL AND WAS UNABLE TO MAINTAIN A LENGTH OF GUIDEWIRE ADVANCED PAST THE DISTAL TIP OF THE CATHETER. ON THE FOURTH OR FIFTH FORCEFUL REMOVAL, THE CATHETER APPEARED TO BECOME DAMAGED, AND THE DISTAL TIP OR GUIDEWIRE BECAME STUCK IN THE HEMOSTATIC VALVE OF THE SHEATH. THE CATHETER WAS PULLED ON UNTIL THE DISTAL TIP FRACTURED FROM THE CATHETER SHAFT. 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 24462137 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE PATIENT HAD ATRIAL TACHYCARDIA. THIS FOLLOWED TREATMENT WITH PULSED FIELD ABLATION ON THE POSTERIOR WALL AND RADIOFREQUENCY ABLATION ON THE MITRAL ISTHMUS. IT WAS ALSO REPORTED THAT ONE DAY POST-OPERATIVELY, TESTING WAS PERFORMED AND CEREBRAL INFARCTION WAS CONFIRMED. THE CAUSE OF THE INFARCTION WAS UNKNOWN. THE OUTCOME OF THIS CASE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA; Tachycardia

  MAUDE report 24454527 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY AFTER A PULSED FIELD ABLATION PROCEDURE, THE PATIENT EXPERIENCED PUNCTURE SITE REBLEEDING AT THE VASCULAR ACCESS SITE. RECOMPRESSION OF THE WOUND WAS PERFORMED, AND RE-SUTURING WAS CONDUCTED. A PRESSURE DRESSING WAS APPLIED AND LATER REMOVED. THE PATIENT RECOVERED AND THE EVENT RESOLVED. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24332489 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU) AND DISCHARGED TWO DAYS LATER.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 24327033 ↗
• MalfunctionFeb 6, 2026Peeled/Delaminated; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE PROVIDER OBSERVED A LONG, NARROW "STRING" OF WHAT APPEARED TO BE PLASTIC REMOVED FROM THE SHEATH AFTER EXTRACTING THE CATHETER. SUBSEQUENTLY, THE CATHETER AND SHEATH WERE REPLACED ALONG WITH ANOTHER MANUFACTURER'S WIRE. THERE WAS ALSO A CABLE CONNECTION ISSUE WHEREIN CATHETER INTERFACE CABLE (CIC) AND CATHETER DISTORTION WERE NOTED ON THE MAPPING SYSTEM. TROUBLESHOOTING INCLUDED UNPLUGGING AND RE-PLUGGING THE CIC MULTIPLE TIMES AT BOTH THE CATHETER AND GENERATOR, AND A NEW RESPIRATORY WAS OBTAINED USING THE ANOTHER MANUFACTURER'S MAPPING SYSTEM. THE CIC WAS REPLACED TO RESOLVE THE DISTORTION. 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 24280256 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, AFTER THE TRANSEPTAL PUNCTURE AND THE SHEATH WAS PASSED INTO THE LEFT ATRIUM, INTRACARDIAC ECHOCARDIOGRAPHY WAS CONDUCTED TO CHECK FOR PERICARDIAL EFFUSION. IT WAS NOTED PERICARDIAL EFFUSION GREATER THAN BA SELINE. VENOUS BLOOD RETURN WAS OBSERVED AND CONFIRMED TO BE FROM A RIGHT ATRIAL SOURCE. THE SHEATH WAS PARKED IN THE RIGHT ATRIUM, AND PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN CONTINUED TO ABLATE THE POSTERIOR WALL ISOLATION AND SUPERIOR VENA CAVA AS WELLAS ISOLATING THE SELECTED PULMONARY VEIN. THE CASE WAS COMPLETED. THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 24260294 ↗
• MalfunctionJan 28, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE AFTER INTRODUCTION OF THE CATHETER THROUGH THE SHEATH. ABLATION WAS MADE BUT THEN 3/4 INTO THE PROCEDURE, FIBROUS MATERIAL WAS NOTED ON THE OUTSIDE OF THE SHEATH. INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING WAS PERFORMED TO CHECK FOR ANY VISUAL REMNANT IN THE LEFT ATRIUM, AND NONE WAS OBSERVED. THE SHEATH WAS REMOVED, AND A NEW SHEATH WAS PREPPED AND INTRODUCED OVER A NEW GUIDEWIRE. THE CASE CONTINUED AND 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 24202671 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE, A PERICARDIAL EFFUSION AND PERFORATION WERE NOTED AND A DROP IN BLOOD PRESSURE WAS OBSERVED. IMAGING OR DIAGNOSTIC ASSESSMENT WAS CONDUCTED TO CHECK FOR EFFUSION. AN EMERGENCY PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CASE OUTCOME IS UNKNOWN. THE PATIENT WAS HOSPITALIZED AND THE EFFUSION RESOLVED WITHOUT FURTHER TREATMENT, AND THE PATIENT WAS DISCHARGED. 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; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 24188749 ↗
• DeathJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT BOTH PULSED FIELD ABLATION AND RADIOFREQUENCY (RF) WERE USED DURING THE PROCEDURE. ADDITIONALLY, THE PHYSICIAN STATED THAT THE PATIENT DIED OF AORTIC DISSECTION A FEW MONTHS AFTER THE PROCEDURE, THE INCIDENT WAS NOT RELATED TO MEDTRONIC PRODUCTS OR PROCEDURE.

  Patient problems: Aortic dissection

  MAUDE report 24161629 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Gas/Air Leak; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, WHEN THE CATHETER WAS INSERTED INTO THE SHEATH AND AIR WAS BEING REMOVED, AIR CONTINUED TO BE DRAWN. THE SIDEPORT TUBE WAS ALSO REPORTED TO HAVE DETACHED FROM THE SHEATH. THE SHEATH 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 23920266 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, CARDIAC TAMPONADE WAS DISCOVERED DURING PRE-MAPPING AND FOLLOWING TRANSEPTAL PUNCTURE. DRAINAGE WAS PERFORMED AND THE PATIENT CONDITION STABILIZED. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 23783659 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PHYSICIAN PULLED BACK INTO THE RIGHT ATRIUM AND PERFORMED SOME ADDITIONAL LESIONS NEAR THE SUPERIOR VENA CAVA (SVC). THE SHEATH WAS MOVED BACK INTO THE LEFT ATRIUM FOR ADDITIONAL ABLATION, BUT IT WAS NOTED THAT THE LEFT ATRIUM LOOKED VERY SMALL ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND HAD TROUBLE GETTING INTO IT. AT THIS POINT, THE SHEATH AND CATHETER WERE BOTH STILL IN THE BODY. THE CATHETER WAS REMOVED OUT OF THE BODY AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), CONFIRMED A PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 23768853 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT A PERICARDIOCENTESIS WAS PERFORMED BUT SURGERY WAS NOT REQUIRED. THE PHYSICIAN BELIEVES THAT THE PATIENT HAD A PREVIOUS 'MASS' WHICH IS THOUGHT TO HAVE CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 23744023 ↗
• MalfunctionDec 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, MANY AIR BUBBLES WERE OBSERVED WHEN FLUSHING THE SHEATH. THIS WAS NOTED AFTER THE CATHETER WAS INSERTED AND FOLLOWING REMOVAL OF THE MAPPING CATHETER. MULTIPLE SYRINGES WERE USED TO REMOVE ALL AIR BUBBLES. 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 23732659 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS POST-OPERATIVELY FROM A SUCCESSFUL ABLATION PROCEDURE WHERE NO ISSUES OCCURRED, THE PATIENT FELL AND LOST CONSCIOUSNESS WHILE WALKING IN THE WARD. MAGNETIC RESONANCE IMAGING (MRI) IMAGING COULD NOT BE PERFORMED AT THE HOSPITAL SO THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. AN MRI WAS PERFORMED AT THE NEW HOSPITAL AND A CEREBRAL INFARCT WAS CONFIRMED. EMERGENCY SURGERY FOR THROMBUS ASPIRATION WAS PERFORMED. THE PATIENT WAS FURTHER HOSPITALIZED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 23649037 ↗
• MalfunctionNov 21, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PULSED FIELD (PF) ABLATION PROCEDURE, AFTER THE PF CATHETER WAS INSERTED INTO THE SHEATH, AIR CONTINUED TO BE DRAWN BACK. THE CATHETER WAS REPLACED, BUT THE ISSUE PERSISTED. THE SHEATH WAS THEN 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 23616899 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PVI PROCEDURE, THE PHYSICIAN WAS HAVING TROUBLE GAINING ACCESS TO THE FEMORAL VEIN WITH THE SHEATH 10FCC13 FLEXCATH CONTOUR 10F. THE DISTAL END OF THE CATHETER WAS FOUND TO BE BENT, WHICH PREVENTED VEIN ACCESS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE CASE WAS COMPLETED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605179 ↗