Dynamic XTRecalls & reported problems across all models

We found 7 models of Dynamic XT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2018 and Aug 4, 2026 — classified as 2 deaths, 15 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 Dynamic XT problems

Dynamic XT models

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

• Dynamic XT™ M0042011010

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 deaths36 reports
• Dynamic XT™ M0042011020

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  6 reports
• Dynamic XT™ M0042011030

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  4 reports
• Dynamic XT™ M0046DYNXT0140

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 reports
• Dynamic XT™ M0042011050

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report
• Dynamic XT™ M0046DYNXT0090

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report
• Dynamic XT™ M0046DYNXT0110

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent Dynamic XT adverse event reports

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

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Pericardial effusion and Cardiac Tamponade occurred.Dynamic XT Electrode Catheter was selected for Single Shot Ablation procedure. It was mentioned that the preparation of the materials (Faradrive sheath and VersaCross Connect wire with dilator) for the transseptal puncture, as well as the advancement of the catheter into the right atrium, proceeded smoothly without any issues. The transseptal puncture was performed under transesophageal echocardiography (TEE) guidance. The physician positioned the transseptal puncture device. Initially, the tenting appeared slightly anterior; however, it was not close to the aorta and was located in the region of the patent foramen ovale (PFO). The physician performing the TEE requested a slight adjustment to optimize the puncture site. Repositioning the device was achieved without difficulty. RF was delivered using the transseptal puncture generator. The wire crossed the interatrial septum in an inferior position, well away from the aorta. After confirming the wire position by both TEE and fluoroscopic imaging, it was visualized in the left superior pulmonary vein. The physician then advanced the Faradrive sheath into the lef

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Pericarditis

  MAUDE report 50133533 ↗
• MalfunctionAug 3, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115122 ↗
• MalfunctionJan 5, 2026Material Perforation; Positioning Problem

  IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER SHAFT WAS DAMAGED. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION, A DYNAMIC XT ELECTRODE CATHETER WAS USED. AFTER INSERTION, IT WAS NOTED THAT THERE WAS DIFFICULTY IN POSITIONING THE DEVICE, AND THE MOVEMENT OF THE CATHETER WAS NOT AS SMOOTH AS USUAL. THE CATHETER WAS THEN WITHDRAWN FOR INSPECTION, WHEREIN A CRACK WAS OBSERVED ON THE DISTAL PORTION OF THE CATHETER SHAFT. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956642 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE AND HAD A PERICARDIAL EFFUSION REQUIRING DRAINAGE. DURING A PULMONARY VEIN ISOLATION (PVI) AND SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE, A DYNAMIC XT ELECTRODE CATHETER WAS USED. AT THE START OF THE CASE, THE PHYSICIAN ATTEMPTED AN ELECTROPHYSIOLOGY (EP) STUDY; HOWEVER, PLACEMENT OF THE CORONARY SINUS (CS) CATHETER WAS EXTREMELY DIFFICULT DUE TO PATIENT'S ANATOMY. THE PHYSICIAN ALTERNATED BETWEEN A DYNAMIC DECAPOLAR CS CATHETER AND AN ABBOTT LIVEWIRE DUODECAPOLAR CATHETER FOR APPROXIMATELY AN HOUR TO GAIN CS ACCESS, BUT CS ACCESS COULD NOT BE ACHIEVED, AND THE EP STUDY PROCEEDED WITHOUT IT. AFTER ADMINISTRATION OF ISUPREL, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CONFIRMED A TRIVIAL PERICARDIAL EFFUSION, WHICH INCREASED SLIGHTLY UPON RE-EVALUATION A MINUTE LATER. CONTINUED MONITORING REVEALED PROGRESSIVE ENLARGEMENT OF THE EFFUSION, WHICH PROMPTED THE USE OF A PERICARDIAL SYNTHESIS KIT TO DRAIN APPROXIMATELY 200 CC OF BLOOD. PROTAMINE WAS ADMINISTERED, AND THE EFFUSION SUBSEQUENTLY STABILIZED. THE PATIENT REMAINED STABLE THROUGHOUT THE INTERVENTION AND WAS KEPT OVERNIGHT FO

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23866200 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE ABLATION PROCEDURE WAS PERFORMED WITH DYNAMIC XT ELECTRODE CATHETER, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED. THE PHYSICIAN BELIEVES THAT THE CORONARY SINUS GOT PERFORATED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER SURGICAL PROCEDURES. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT HAS ALREADY BEEN DISPOSED.

  Patient problems: Pericardial Effusion

  MAUDE report 23705602 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE IS BROKEN AND DETACHED AT THE CATHETER TIP. A DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593930 ↗
• MalfunctionApr 29, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULT TO WITHDRAW AND DIFFICULT TO ADVANCE. DURING RADIO FREQUENCY PROCEDURE TO TREAT ATRIAL FLUTTER AT SIDE BRANCH TO THE SINUS CORONARIUS, A DYNAMIC XT WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER WAS ENTANGLED IN A SIDE BRANCH TO THE SINUS CORONARIUS. WHEN THE CATHETER WAS REMOVED, THERE WAS SOME KIND OF DEFECT BETWEEN ELECTRODES 1 AND 2 AND IT GOT STUCK IN A SIDE BRANCH TO SINUS CORONARIUS AND IT COULDN'T GET IT OUT. NO RESISTANCE FELT WHILE MANEUVERING THE CATHETER. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928645 ↗
• MalfunctionApr 29, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO WITHDRAW AND DIFFICULT TO ADVANCE. DURING A PROCEDURE TO TREAT A SUPRAVENTICULAR TACHYCARDIA AT SINUS CORONARIUS, A DYNAMIC XT CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER WENT ENTRAPPED IN A SIDE BRANCH TO SINUS CORONARIUS. IT COULD NOT BE WITHDRAWN OR PUSHED FORWARD. THE CATHETER HAD TO BE ROTATED COUNTERCLOCKWISE TO BE REMOVED. THERE WAS A NOTICEABLE DAMAGE AT THE TIP BETWEEN THE DISTAL TIP ELECTRODE AND POLE 2, IT LOOKS LIKE THE DIAMETER IS SLIGHTLY LARGER, IT WASN'T SURE IF THAT DEFECT WAS CREATED AFTER THE CATHETER GOT STUCK AND THEY TRIED TO ROTATE IT OUT. IF THIS DEFECT WAS THERE FROM THE BEGINNING, NO ONE KNOWS. THE PHYSICIAN DIDN'T HAVE TROUBLE INSERTING THE DEVICE. IT WAS 5 OR 6 F OF THE SIZES AND TYPES OF SHEATHS. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928403 ↗
• MalfunctionMar 25, 2025

  DECA CATHETER WOULD NOT BEND CORRECTLY FOR MD (MEDICAL DOCTOR). CATHETER WAS REMOVED AND REPLACED WITH NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686863 ↗
• MalfunctionOct 18, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  THE DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT WHEN THE OUTER PACKAGE OF THE DEVICE WAS REMOVED, THEY FOUND THE PLASTIC PROTECTIVE SLEEVE OUTSIDE THE CATHETER WAS FRACTURED. THE DEVICE WAS CONTAMINATED AND COULD NOT BE USED DUE TO DAMAGE TO THE PROTECTIVE SLEEVE. CATHETER WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488681 ↗
• MalfunctionAug 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. CATHETER ELECTRODE MAPPING SIGNAL WAS UNSTABLE. PROCEDURE WAS UNABLE TO BE COMPLETED AND HAD TO BE CANCELLED/RESCHEDULED. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050135 ↗
• MalfunctionAug 10, 2024Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT), A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. ON OPENING STERILE PACKAGING, SCOUT NURSE IDENTIFIED A SMALL FIBER THAT APPEARED TO REPRESENT A HAIR/STRAND OF GLUE ATTACHED NEAR A JOIN TOWARD THE END OF THE BLACK SECTION OF THE HANDLE. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957764 ↗
• MalfunctionJun 18, 2024Packaging Problem; Packaging Problem

  THE DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR A ABLATION PROCEDURE. PRIOR TO USE, IT WAS NOTED THAT THE PLASTIC OUTER PACKAGING OF THE DEVICE WAS DAMAGED AND NO LONGER STERILE. THE DEVICE WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. IT IS UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559727 ↗
• DeathFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED FOLLOWING A PROCEDURE WHILE USING TWO INTELLAMAP ORION CATHETERS AND A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER. DURING MAPPING AND ABLATION PROCEDURE TO TREAT A LEFT ACCESSORY PATHWAY ARRYTHMIA, THE INTELLAMAP ORION CATHETER WAS NOTED TO BE HARD TO MANIPULATE BECAUSE IT WAS BENT. THE PHYSICIAN REPLACED THE FIRST ORION BECAUSE THE CATHETER WAS NOT REACTED PROPERLY TO MANEUVERS. THE ISSUE WAS RESOLVED WITH THE SECOND CATHETER. THE DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS PLACED IN THE CORONARY SINUS (CS). WHILE THE PHYSICIAN WAS MANIPULATING THE ORION CATHETER IN BETWEEN THE AORTA AND THE LEFT VENTRICLE THE PATIENT FELT PAIN, THE PHYSICIAN REALIZED THEY SUFFERED A LEFT VENTRICLE CARDIAC TAMPONADE. IT WAS UNKNOWN IF THE TAMPONADE WAS CAUSED BY THE FIRST OR SECOND ORION CATHETER. THE TAMPONADE OCCURRED PRIOR TO ABLATION; NO ABLATION CATHETER WAS USED. PERICARDIOCENTESIS WAS PERFORMED. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING WAS PERFORMED TO ATTEMPT TO LOCATE A SUSPECTED PERFORATION. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT DIED THE FOLLOWING DAY. THE CAUSE OF DEATH WAS RELATED TO THE TAMPONADE. NO FURTHER INFORMATION ON PATIENT C

  Patient problems: Cardiac Tamponade

  MAUDE report 18788394 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OT WAS REPORTED THAT FOLLOWING A PROCEDURE USING A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER THE PATIENT EXPERIENCED CARDIAC TAMPONADE. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY AND WHILE IN THE RECOVERY AREA THE PATIENT BECAME TACHYCARDIC, HYPOTENSIVE, AND DIAPHORETIC. AN ECHO WAS PERFORMED, AND TAMPONADE WAS IDENTIFIED. A PERICARDIOCENTESIS WAS PERFORMED AND THE EFFUSION WAS RESOLVED. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. THEY ARE EXPECTED TO MAKE A FULL RECOVERY. THE CAUSE OF THE EFFUSION COULD NOT BE DETERMINED. THE CATHETER IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 18187358 ↗

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