CARTO VIZIGO D138504Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 10846835026252), received between Apr 30, 2024 and Sep 30, 2026 — classified as 2 deaths, 20 injuries, 266 malfunctions.

The most frequently reported specific device problem is “Backflow” (117 reports).

7 other recalls cover devices cleared under the same FDA submission (K170997); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951523 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  It was reported that a patient underwent a cardiac ablation procedure with CARTO VIZIGO and there was damage to the orange valve of the VIZIGO. It was noted during post mapping acquisition. It was determined that air would not be drawn in because continuous perfusion saline was flowing back from the valve. The post-map was completed as quickly as possible and the procedure was completed. There was no patient consequence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928968 ↗
• MalfunctionSep 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920066 ↗
• MalfunctionSep 25, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905511 ↗
• InjurySep 25, 2026Positioning Problem; Patient 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 perforation with required surgical intervention.Approximately 20 minutes after initiation of pulmonary vein isolation and after approximately 20 ablations had been performed, the patient's blood pressure suddenly decreased, and pericardial effusion was confirmed by echocardiography. Thoracotomy was performed, and blood transfusion was administered. The patient's blood pressure returned to normal with extracorporeal membrane oxygenation (ECMO). A perforation was located at the tip of the left atrial appendage. The patient required extended hospitalization. The patient¿s condition has improved.Transseptal puncture was performed with Scooper RF needle 89 cm (RFN-89Dnx).Physician's assessment of health hazard is serious. Physician's comment regarding relationship between the event and the product is that there was an occasion when the VIZIGO lost deflection. At that time, it was suspected that the VARIPULSE Catheter may have been caught on something inside the cardiac chamber. While the VIZIGO sheath was in a straight

  Patient problems: Cardiac Perforation

  MAUDE report 50900049 ↗
• MalfunctionSep 25, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898145 ↗
• MalfunctionAug 22, 2026Difficult to Advance; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383936 ↗
• MalfunctionAug 10, 2026Material Separation

  It was reported that a patient underwent an Atrial Fibrillation (AFib) procedure with two CARTO VIZIGO sheaths and hemostatic valve dislodgement issues were observed.Dislodgement of the hemostatic valve was observed during setup. The sheath was replaced. However, the hemostatic valve of the new sheath was also dislodged and it was a product of the same lot. The issue was resolved by replacing the CARTO VIZIGO sheath of a different lot. There was no patient consequence reported.Additional information was received on 23-Jul-2026. The sheath was not used on the patient. No needle was involved in the alleged event.Additional information was received on 26-Jul-2026. The hemostatic valve was dislodged inside the hub. The brim cap was not detached from the sheath. The hub was not detached from the sheath.The two CARTO VIZIGO sheaths with the hemostatic valve dislodgement issues were assessed as MDR reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201006 ↗
• MalfunctionAug 5, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136744 ↗
• InjuryJul 17, 2026Material Separation; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND THE PATIENT EXPERIENCED AIR EMBOLISM THAT REQUIRED ASPIRATION WITH A PIGTAIL CATHETER. AFTER PERFORMING PRE-MAPPING OF LEFT ATRIUM, VIZIGO PRIMING WAS PERFORMED AND AIR WAS CONFIRMED TO HAVE BEEN ASPIRATED INTO THE SYRINGE. NO SPECIFIC ERROR WAS OBSERVED. THE HEMOSTATIC VALVE DISLODGED INSIDE THE HUB. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN/CRACKED. FLUOROSCOPY CONFIRMED THE PRESENCE OF AIR IN THE RIGHT ATRIUM WHICH WAS SUBSEQUENTLY ASPIRATED USING A PIGTAIL CATHETER. CORONARY ANGIOGRAPHY WAS ALSO PERFORMED. AT THE TIME OF LEAVING THE PROCEDURE ROOM, THE HEMODYNAMIC STATUS WAS UNCHANGED FROM BASELINE, AND NO CEREBRAL INFARCTION OR OTHER COMPLICATIONS WERE OBSERVED THE FOLLOWING DAY. PATIENT WAS ASYMPTOMATIC. MAGNETIC RESONANCE IMAGING WAS PERFORMED BUT NO CEREBROVASCULAR ACCIDENT OCCURRED. THERE WAS NO EVIDENCE OF CHAR NOR BLOOD THROMBUS/CLOT. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT THE TIP OF THE VIZIGO WAS IN CONTACT WITH THE MYOCARDIUM, AND IT IS POSSIBLE THAT NEGATIVE PRESSURE WAS GENERATED DURING AIR PURGING, RESULTING IN AIR BEING ASPIRATED. DAMAGE TO THE HEMOSTATIC VALVE A

  Patient problems: Air Embolism

  MAUDE report 25860936 ↗
• MalfunctionJul 15, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834195 ↗
• MalfunctionJul 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834130 ↗
• MalfunctionJul 14, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AIR WAS BEING DRAWN INTO THE VIZIGO. DURING PLACEMENT OF THE VIZIGO INTO THE PATIENT¿S BODY, AIR WAS BEING DRAWN INTO THE VIZIGO. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817697 ↗
• MalfunctionJul 13, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808234 ↗
• MalfunctionJul 8, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR WAS BEING DRAWN IN FROM THE HEMOSTATIC VALVE. WHEN THE SOUND STAR ECO CATHETER WAS INSERTED AFTER PUNCTURE, AIR WAS BEING DRAWN IN FROM THE HEMOSTATIC VALVE OF THE VIZIGO SHORT. NO AIR WAS INTRODUCED INTO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE ISSUE WAS HANDLED BY REPLACING THE SHEATH. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750525 ↗
• MalfunctionJun 29, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR WAS CONTINUOUSLY BEING DRAWN IN THROUGH THE SIDE PORT. DURING THE INITIAL AIR REMOVAL AFTER INSERTION INTO THE PATIENT¿S BODY, AIR WAS CONTINUOUSLY DRAWN IN THROUGH THE SIDE PORT OF THE VIZIGO. THE SHEATH WAS USED ON PATIENT, BUT NO AIR ENTERED THE PATIENT AND NO BLOOD RETURN WAS OBSERVED. THE HEMOSTATIC VALVE WAS NOT DISLODGED INSIDE OR OUTSIDE OF THE HUB AND THE BRIM CAP/HUB DID NOT DETACH FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650323 ↗
• MalfunctionJun 17, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND AFTER THE PROCEDURE, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE WAS PEELED BACK. THE MEDICAL TEAM STATED THAT THE DAMAGE MOST LIKELY OCCURRED DURING FEMORAL PUNCTURE OR DURING SEPTAL PUNCTURE. NO TROUBLESHOOTING OCCURRED AS THE DAMAGE WAS NOTED POST PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535754 ↗
• InjuryJun 12, 2026Mechanical Jam; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VARIPULSE CATHETER AND A VIZIGO SHEATH AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. FIRST IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED INTO THE PATIENT¿S BODY, ELECTRODE #10 WAS DISPLAYED IN BLACK FOR THE VARIPULSE CATHETER WITH LOT# 31817950L. THE CATHETER WAS REPLACED WITH ANOTHER NEW VARIPULSE CATHETER WITH LOT # 31814177L AND THE ISSUE WAS RESOLVED. THEN IT WAS REPORTED THAT DURING ABLATION, PULL WIRE DISCONNECTION OCCURRED WITH THE VIZIGO SHEATH WITH LOT # 17411932. ADDITIONAL ABLATION WAS DISCONTINUED AND A POST-MAP WAS CREATED TO CONFIRM THE GAP, AND THE VARIPULSE CATHETER (LOT: 31814177L) WAS REINSERTED FOR ADDITIONAL ABLATION. HOWEVER, THIS WAS PERFORMED BECAUSE THE VIZIGO SHEATH LOT # 17411932 DID NOT MOVE AS EXPECTED. THE VIZIGO SHEATH LOT # 17411932 WAS REPLACED WITH THE ANOTHER NEW ONE. THEN, APPROXIMATELY 1¿2 MINUTES AFTER MANIPULATION OF THE VARIPULSE CATHETER AND VIZIGO SHORT DURING PREPARATION FOR VIZIGO SHORT REPLACEMENT, A DECREASE IN BLOOD PRESSURE WAS NOTED AND A CARDIAC TAMPONADE OCCURRED. DRAINAGE WAS PERFORMED, AND THE PROCEDURE WAS COMPLETE

  Patient problems: Cardiac Tamponade

  MAUDE report 25488349 ↗
• MalfunctionJun 8, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO AND AFTER THE INITIAL CATHETER INSERTION, AIR WAS CONTINUOUSLY DRAWN FROM THE HEMOSTATIC VALVE. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHORT WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT AIR WAS CONFIRMED ONLY IN THE SIDE PORT. NO DAMAGE WAS OBSERVED EXTERNALLY. THE PHYSICIAN HAD AN INTACT BS ECG AT POLYGRAPH AVAILABLE WHEN THE NOISE ISSUE OCCURRED. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438276 ↗
• MalfunctionJun 3, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THE MEDICAL TEAM WAS UNABLE TO ACCESS THE LEFT ATRIUM--THE TIP OF THE SHEATH WAS FOLDING. THE ISSUE WAS NOTED 30 MINUTES AFTER THE START OF ABLATION. THE VIZIGO WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25377653 ↗
• MalfunctionMay 26, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND INSERTING A TRANSSEPTAL PUNCTURE NEEDLE (XEROSTAR) INTO THE SHEATH AND PERFORMING TRANSSEPTAL PUNCTURE, THE PHYSICIAN REPORTED ENCOUNTERING RESISTANCE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25282548 ↗
• MalfunctionMay 18, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND DURING BROCKENBROUGH PUNCTURE, THE RADIOFREQUENCY WIRE, XEROSTAR, JAPAN LIFELINE CO., (NON-BIOSENSE WEBSTER INC (BWI)), COULD NOT BE INSERTED INTO THE DILATOR OF THE VIZIGO SHORT. THE XEROSTAR WIRE WAS REPLACED WITH AN ACUSAFE WIRE (NON-BWI). THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211086 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND AFTER THE SHEATH WAS INSERTED INTO THE PATIENT¿S BODY, REVERSE BLOOD WAS OBSERVED AT THE HEMOSTATIC VALVE. NO DAMAGE WAS OBSERVED, AND THERE WERE NO APPARENT EXTERNAL ABNORMALITIES SUCH AS DISLODGEMENT OF THE HEMOSTATIC VALVE. IT OCCURRED AFTER THE MAPPING CATHETER WAS INSERTED. VIZIGO SHORT WAS REPLACED BASED ON THE PHYSICIAN'S JUDGMENT. A FEW DROPS OF BLOOD WERE OBSERVED; HOWEVER, THE EXACT AMOUNT IS UNKNOWN. NO NEEDLE PRODUCT WAS USED WITH THE VIZIGO SHEATH. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156338 ↗
• MalfunctionMay 12, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INVOLVED USAGE OF VIZIGO SHEATHS. HOWEVER, THE FIRST TWO SHEATHS HAD THE SAME ISSUE: AIR DRAWN INTO THE SIDE PORT. DURING THE FIRST INSERTION OF THE VARIPULSE CATHETER INTO THE SHEATH, AIR WAS CONTINUOUSLY DRAWN INTO THE SIDE PORT. WHEN THE SHEATH WAS REPLACED, THE SAME ISSUE OCCURRED WITH THE SECOND SHEATH. THE ISSUES DID NOT RESOLVE DESPITE THE USE OF AN AIR TRAY. BOTH SHEATHS HAD BEEN REPLACED AND THE PROCEDURE WAS COMPLETED USING A THIRD SHEATH. NO AIR WAS DRAWN INTO THE PATIENT'S BODY. NO PATIENT CONSEQUENCES WERE REPORTED. THERE ARE TWO REPORTS FOR THE FIRST TWO VIZIGO SHEATHS. THIS REPORT IS FOR LOT 60000681.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152909 ↗
• MalfunctionMay 12, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INVOLVED USAGE OF VIZIGO SHEATHS. HOWEVER, THE FIRST TWO SHEATHS HAD THE SAME ISSUE: AIR DRAWN INTO THE SIDE PORT. DURING THE FIRST INSERTION OF THE VARIPULSE CATHETER INTO THE SHEATH, AIR WAS CONTINUOUSLY DRAWN INTO THE SIDE PORT. WHEN THE SHEATH WAS REPLACED, THE SAME ISSUE OCCURRED WITH THE SECOND SHEATH. THE ISSUES DID NOT RESOLVE DESPITE THE USE OF AN AIR TRAY. BOTH SHEATHS HAD BEEN REPLACED AND THE PROCEDURE WAS COMPLETED USING A THIRD SHEATH. NO AIR WAS DRAWN INTO THE PATIENT'S BODY. NO PATIENT CONSEQUENCES WERE REPORTED. THERE ARE TWO REPORTS FOR THE FIRST TWO VIZIGO SHEATHS. THIS REPORT IS FOR LOT 60000682.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152901 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170997. One submission often covers many models, so check the product and lot details in each record.

• Z-1290-2024 · Feb 16, 2024 · Open, Classified
  CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac a
• Z-1319-2023 · Feb 21, 2023 · Open, Classified
  Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
• Z-1320-2023 · Feb 21, 2023 · Open, Classified
  Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
• Z-1677-2022 · Jun 29, 2022 · Open, Classified
  CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
• Z-1287-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide access
• Z-1285-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessi
• Z-1286-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessi