VARIPULSE™ Bi-Directional Catheter D141201Recalls & reported problems

Summary

The FDA's MAUDE database contains 273 adverse event reports that list this exact device (DI 10846835025460), received between Dec 10, 2024 and Sep 30, 2026 — classified as 3 deaths, 210 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (210 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Jan 5, 2025Class ICompleted

   Due to an observed trend of neurovascular events

   Z-1205-2025 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 273 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954838 ↗
• InjurySep 29, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VARIPULSE Bi-Directional Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.Transseptal puncture was performed with a Radiofrequency (RF) needle (Boston Scientifics). A total of 16 ablations by pulse field ablation was done. The procedure was completed without issue. After sheath removal, the patient's blood pressure decreased, and a cardiac tamponade was discovered. Pericardial drainage was performed, and the blood pressure subsequently stabilized. The patient was under observation and has fully recovered.Physician's judgment on health hazard is that it was non-serious (moderate/minor). The physician's comment regarding relationship between the event and the product is that as the VARIPULSE Catheter was used only within the left atrium and the drained blood was venous blood; the issue was considered unlikely to be related to the device. The physician believes it was procedure related. There were no abnormalities observed prior to or during product use.

  Patient problems: Cardiac Tamponade

  MAUDE report 50935392 ↗
• MalfunctionSep 29, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935154 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50921727 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50918183 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50900050 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation cardiac ablation procedure with a VARIPULSE Bi-Directional Catheter and the patient experienced cardiac tamponade which required pericardiocentesis and prolonged hospitalization.During the procedure a pericardial effusion occurred. It was discovered towards the end of the case as they were doing the post intracardiac echocardiogram imaging, the pericardial effusion was then confirmed. The physician performed pericardiocentesis and drained 350cc of fluid. A foley device was left in the patient for observation while in the intensive care unit for the night. The patient is currently in stable condition and awake. The physician is not aware of how and when the injury occurred since it was confirmed at the end of the procedure.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50893067 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  Patient problems: Stroke/CVA

  MAUDE report 50891503 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation and the patient experienced phrenic nerve palsy that required CPAP therapy.During right superior pulmonary vein (RSPV) ablation, phrenic nerve palsy occurred. Pulmonary vein isolation (PVI) was performed, and the procedure was completed. The patient left the catheterization room while receiving continuous positive airway pressure (CPAP) therapy. An X-ray examination was scheduled for a later date.The physician considered that the issue was related to RPV ablation. This was a Varipulse Plus procedure.

  Patient problems: Paralysis

  MAUDE report 50889336 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation with a VARIPULSE¿ Bi-Directional Catheter and the patient experienced bleeding that required hospitalization.It was reported that the case was uneventful. After the procedure it was learned that the patient was bleeding from the mouth. The patient was left on the ventilator and sent to ICU (intensive care unit). There are no planned interventions at this time.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50879410 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation and the patient experienced a pulmonary embolism and retroperitoneal bleed.First, it was reported that after the medical team went transeptal the body surface signals were attenuated. They replaced the 12 lead cable and patches and the issue did not resolve. They changed ports and the issue did not resolve. They unseated the sheath from the PIU (patient interface unit) and the issue resolved. The sheath was replaced and the case continued.Then it was reported that the patient went to recovery post procedure and it was found that the patient had a possible stroke and a retroperitoneal bleed through CT (computed tomography). The patient was cleared of a stroke by CT imaging but may have had a pulmonary embolism. The plan was to get an MRI.There are three reports for this event, one for the Varipulse, Vizigo sheath (lot 00003186), and an unknown lot of Vizigo sheath. This report is for the Varipulse.

  Patient problems: Pulmonary Embolism

  MAUDE report 50872393 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  Patient problems: Stroke/CVA

  MAUDE report 50862924 ↗
• InjurySep 22, 2026Patient Device Interaction Problem

  Patient problems: Stroke/CVA

  MAUDE report 50860796 ↗
• MalfunctionSep 22, 2026Obstruction of Flow

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure and after ablation with a VARIPULSE¿ Bi-Directional Catheter, they noticed the SmartAblate Irrigation Tubing Set was disconnected at the catheter end (no damage noticed). There were no errors displayed. The pump was flowing, just not into the catheter, and there was no pool of fluid found. They also cardioverted, and there was no injury to patient. Additional information indicated that it is not known exactly how it became disconnected. Mid-way through the case, the physician noticed that it got disconnected and the issue was resolved. It is suspected that it came off during the cardioversion (planned), however, it remains unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850135 ↗
• MalfunctionSep 17, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809221 ↗
• DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a paroxysmal atrial fibrillation (Afib) cardiac ablation procedure with a VARIPULSE Bi-Directional Catheter and the patient expired.After pulse field ablation (PFA) Afib ablation they attempted Watchman left atrial appendage occlusion (LAAO) device placement on 31-Jul-2026, the patient developed heart failure and passed away.The PFA procedure for Afib with TruPulse/VariPulse was unremarkable. Forty-two (42) PFA applications were delivered, Carto mapping was performed with the PentaRay catheter, nothing out of the ordinary occurred during the procedure and the patient was stable afterward. Varipulse Plus settings of 30mL/min ablation irrigation flow rate, manual switching to 4mL/min idle, Inter Application Delay 10 seconds were used during the procedure. After the Pulmonary Vein Isolation (PVI) portion of the procedure the physician attempted to implant the Watchman LAAO device. This procedure was aborted as it was determined that the patient's appendage was too large for implantation. The patient left the lab on (b)(6) in stable condition.The day following the procedure, (b)(6) 2026, the patient returned to the hospital emergency room with h

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50781823 ↗
• InjurySep 15, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation (Afib) cardiac ablation procedure with a VARIPULSE¿ Bi-Directional Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.The patient had a pericardial effusion which was noticed while doing a post-map ultrasound check at the end of the procedure. The effusion was also confirmed with fluoroscopy and ultrasound. Pericardiocentesis was performed on the patient and 550cc was drained. The patient's last known status was stable and were being admitted to the ¿CCU¿.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50776356 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  Patient problems: Stroke/CVA

  MAUDE report 50744499 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  It was reported that a patient underwent pulmonary vein isolation and cavotricuspid isthmus (CTI) ablation and the patient experienced pericarditis.Three days after the case, patient experienced acute breathlessness, and sore while lying on back. The patient went to "NHS". No pericardial effusion on echo, but symptoms consistent with pericarditis. It was also reported that there was an indication that ST change on electrocardiogram may be a vagal response.On review of the case details from the CARTO system, 37 radiofrequency (RF) lesions were delivered at the CTI with the THERMOCOOL SMARTTOUCH SF catheter. Pulmonary vein isolation was performed with the VARIPULSE¿ Bi-Directional Catheter Plus workflow - 4 ablations per vein/16 total, with 4ml/min passive irrigation and 30ml/min during pulsed field ablation (PFA) application. The physician indicated initially that he thought the potential pericarditis could have been a result of PFA, although once he saw the number of RF lesions, he determined the CTI ablations would be a more likely cause for any pericarditis/symptoms experienced by the patient in the days following the procedure.

  Patient problems: Ischemic Heart Disease; Pericarditis

  MAUDE report 50726562 ↗
• MalfunctionSep 9, 2026Coagulation in Device or Device Ingredient

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698556 ↗
• MalfunctionAug 24, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421332 ↗
• InjuryAug 20, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation procedure with a VARIPULSE¿ Bi-Directional Catheter and the patient experienced a cardiac tamponade which required hospitalization. Pericardial effusion occurred on the second day after the ablation procedure. The patient had a blood pressure decrease. No drainage was performed. However, the patient required extended hospitalization and was discharged after several days. Physician assessment of the health hazard is non-serious (moderate/minor). The physician believes that the endocarditis was caused by excessive temperature elevation during PFA using the VARIPULSE catheter. During the procedure, mechanical needle was used for transseptal puncture. The flow settings of the irrigation catheter were 30 mL/min during and before/after ablation, 4 mL/min otherwise. There were no abnormalities observed prior to or during product use.

  Patient problems: Cardiac Tamponade; Endocarditis

  MAUDE report 50358081 ↗
• InjuryAug 14, 2026Patient Device Interaction Problem

  Patient problems: Dyspnea

  MAUDE report 50260551 ↗
• InjuryJul 31, 2026High Readings; Patient Device Interaction Problem

  It was reported that a patient underwent a persistent atrial fibrillation ablation procedure with a VARIPULSE CATHETER and the patient experienced acute respiratory distress syndrome that required manual ventilation.Two minutes after the error 311 'current too high during ablation' on the Trupulse Monitor, the O2 of the patient dropped to 60%. The nurses had to manually ventilate the patient as she was not breathing properly anymore. After 2-3 minutes the O2 saturation recovered back to 90%. The procedure was successfully completed. In the physician¿s opinion this happened due to the sedation with propofol.

  Patient problems: Respiratory Failure

  MAUDE report 50094395 ↗
• InjuryJul 30, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation and the patient experienced cardiac tamponade that required drainage.Cavotricuspid isthmus (CTI) ablation was performed using the QDOT MICRO Catheter and VIZIGO Short. Brockenbrough (BB) was performed using the Soundstar eco catheter. Pulmonary vein isolation (PVI) was performed using the VARIPULSE Catheter, and post-mapping of the left atrium (LA) was performed using OCTARAY. After completion of these procedures, the physician observed a decrease in blood pressure, confirmed using echocardiography, which revealed pericardial effusion. The patient's blood pressure recovered and stabilized after drainage, and the patient left the room.It was stated that the drained blood was venous blood, so the issue might have been related to ablation near the inferior vena cava (IVC), during CTI ablation, or to coronary sinus (CS) catheter insertion.Visitag coloring setting was Tag index. Visitag additional filter used was FOT. Force visualization features were used were CF, Realtime Graph, Vector, Visitag. Parameters for stability were: range: 3mm, time: 3sec, FOT: 25%5g, tag size: 2mm. Procedural activated clotting time was 350 seconds

  Patient problems: Cardiac Tamponade

  MAUDE report 50091229 ↗