FlexCath Cross Transseptal Solution 900310Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850027837970), received between Oct 3, 2024 and Jul 27, 2026 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that post-operatively to a pulse field ablation procedure, cardiac tamponade occurred and drainage was performed that night due to a pericardial effusion as well. No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50009544 ↗
• InjuryNov 4, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING THE NDL 900310 FLEXCATH CROSS FCC 10FR, THERE WAS DIFFICULTY PASSING THE INTEGRATED DILATOR/NEEDLE OVER THE GUIDEWIRE, AND A DEFORMITY WAS NOTED ON THE TIP OF THE INTEGRATED DILATOR/NEEDLE AFTER THE SHEATH AND NEEDLE WERE REMOVED. THE PATIENT EXPERIENCED SUSPECTED VENOUS DISSECTION, LOW BLOOD PRESSURE, AND VASCULAR INJURY. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA BEFORE TRANSSEPTAL DEVICE USAGE, AND NO ABLATION WAS PERFORMED. THE PATIENT RECEIVED A UNIT OF BLOOD AND FLUIDS, AND A BALLOON INTERVENTION WAS PERFORMED TO THE VEIN. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23470047 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT LOST ONE LITER OF BLOOD. THE PATIENT THEN UNDERWENT SURGERY TO REPAIR A PERFORATION IN THE RIGHT VENTRICULAR (RV) APEX.

  Patient problems: Bradycardia; Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 23451153 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PULSED FIELD ABLATION PROCEDURE, THE PATIENT HAD A SMALL PERICARDIAL EFFUSION AT BASELINE PRIOR TO THE PROCEDURE. THE PATIENT WAS FOUND TO HAVE A PERICARDIAL EFFUSION LARGER THAN BASELINE, AS OBSERVED ON INTRACARDIAC ECHOCARDIOGRAM. A PULMONARY VEIN ISOLATION AND TYPICAL FLUTTER ABLATION HAD BEEN COMPLETED PRIOR TO THIS FINDING. THE PATIENT WAS UNABLE TO MAINTAIN BLOOD PRESSURE DUE TO THE EFFUSION, NECESSITATING A PERICARDIOCENTESIS, DURING WHICH 240CCS OF BLOOD WERE REMOVED FROM THE PERICARDIAL SPACE. THE PERICARDIOCENTESIS STABILIZED THE PATIENT, WHO WAS SUBSEQUENTLY EXTUBATED AND HAD ALL SUPPORTING MEDICATIONS DISCONTINUED BEFORE LEAVING THE LAB. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT POST-PROCEDURE, WITH A PERICARDIAL DRAIN REMAINING IN PLACE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23005268 ↗
• DeathSep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE THE PATIENT PASSED AWAY. IT WAS NOTED THAT THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE AND A SUDDEN DECREASE IN OXYGEN SATURATION, WHILE ABLATING IN THE RIGHT SUPERIOR PULMONARY VEIN. THE PATIENT SUBSEQUENTLY EXPERIENCED A CARDIAC ARREST, NECESSITATING CARDIOPULMONARY RESUSCITATION MEASURES. INTRACARDIAC ECHOCARDIOGRAM SHOWED A SIMILAR BASELINE EFFUSION PRIOR TO ABLATION, AND AN ECHOCARDIOGRAM PERFORMED BY THE ANESTHESIA, REVEALED A LARGE RIGHT VENTRICULAR CLOT. ACTIVATED CLOTTING TIME WAS MEASURED MULTIPLE TIMES, WITH RESULTS OF 190, 211, AND 186. THE PATIENT RECEIVED 15,000 UNITS OF HEPARIN, FOLLOWED BY ADDITIONAL DOSES OF ANTICOAGULANT, MULTIPLE ROUNDS OF EPINEPHRINE, BICARBONATE, AND ANTICHOLINERGIC MEDICATIONS. AN IMPELLA DEVICE WAS INSERTED INTO THE LEFT VENTRICLE. DESPITE RESUSCITATION EFFORTS FOR ONE HOUR, THE PATIENT COULD NOT BE REVIVED AND EXPIRED ON THE TABLE. THE PHYSICIAN ATTRIBUTED THE EVENT TO A LARGE PULMONARY EMBOLISM.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pulmonary Embolism

  MAUDE report 22931984 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING THE NDL 900310 FLEXCATH CROSS FCC 10FR AND SHEATH 10FCC13 FLEXCATH CONTOUR 10F, THE PROCEDURE WAS ABORTED AFTER A LARGE "CLOT" WAS VISUALIZED IN THE LEFT ATRIUM ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOLLOWING TRANSSEPTAL PUNCTURE AND MAPPING CATHETER INSERTION. ICE WAS INITIALLY USED TO CONFIRM THE ABSENCE OF EFFUSION OR CLOT BEFORE THE TRANSSEPTAL PUNCTURE. AFTER THE EVENT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED TO VERIFY THE LOCATION OF THE "CLOT" OR TISSUE. THE PATIENT WAS ADEQUATELY ANTICOAGULATED THROUGHOUT THE PROCEDURE. INTERVENTIONAL RADIOLOGY SUCTIONED THE MATERIAL FROM THE LEFT ATRIUM USING A SMALLER CATHETER THROUGH THE FLEXCATH CONTOUR SHEATH, AND IT WAS DETERMINED TO BE TISSUE BELIEVED TO HAVE BEEN ATTACHED TO THE SEPTUM OR PUSHED INTO THE LEFT ATRIUM DURING THE TRANSSEPTAL PUNCTURE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED AS A PRECAUTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22902061 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL PULMONARY VEIN ISOLATION (PVI) PROCEDURE USING THE PULSESELECT CATHETER, A PERICARDIAL EFFUSION OCCURRED DURING THE CAVO-TRICUSPID ISTHMUS (CTI) LINE ABLATION WITH ANOTHER MANUFACTURER'S RADIOFREQUENCY (RF) CATHETER. THE ONLY PRODUCT PRESENT IN THE PATIENT AT THAT TIME THE PERICARDIAL EFFUSION WAS OBSERVED WAS THE CONTOUR SHEATH. THE PERICARDIAL EFFUSION WAS DETECTED, AND A PERICARDIOCENTESIS WAS PERFORMED AS TREATMENT. THE EVENT LED TO AN EXTENDED HOSPITALIZATION FOR THE PATIENT. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 22307353 ↗
• InjuryOct 3, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE AMPLATZ EXTRA STIFF GUIDEWIRE KINKED AS THE INTEGRATED DILATOR/NEEDLE WAS INSERTED PAST THE LEVEL OF THE PATIENT'S SKIN. THE SYSTEM WAS REMOVED FROM THE PATIENT. A NEW GUIDEWIRE WAS INSERTED AND THE SYSTEM RE-INSERTED SUCCESSFULLY. THE TRANSSEPTAL PUNCTURE WAS PERFORMED SUCCESSFULLY. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. THREE HOURS POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN AND THE PATIENT'S VITAL SIGNS DROPPED WHICH INCLUDED A VAGAL EPISODE, BRADYCARDIA, AND HYPOTENSION. A COMPUTERIZED TOMOGRAPHY (CT) AND CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE PERFORMED AND CONFIRMED A RIGHT EXTERNAL ILIAC VENOUS PSEUDOANEURYSM. THE RETROPERITONEAL BLEED REQUIRED INTERVENTION WITH BLOOD PRODUCTS AND EXTENDED THE PATIENT'S HOSPITALIZATION. THE PATIENT WAS REPORTED STABLE THROUGHOUT. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN BELIEVED THE BLEED OCCURRED AS A RESULT OF THE FIRST ATTEMPT TO INSERT THE FLEXCATH CROSS PRODUCT DURING THE PROCEDURE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Pain; Pseudoaneurysm; Retroperitoneal Hemorrhage

  MAUDE report 20363182 ↗