CARTO VIZIGO D138505Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10846835026269), received between Jun 5, 2024 and May 18, 2026 — classified as 4 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Backflow” (21 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND THE HEMOSTATIC VALVE WAS DISLODGED. 30 MINUTES AFTER THE START OF USE, THE HEMOSTATIC VALVE WAS DISLODGED. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING NO AIR ENTERED THE PATIENT¿S BODY AND NO BLOOD RETURN WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211731 ↗
• MalfunctionMay 14, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR WAS DRAWN IN FROM THE SIDE PORT. IMMEDIATELY AFTER THE VARIPULSE CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS DRAWN IN FROM THE SIDE PORT. AFTER SEVERAL TIMES OF FLUSHING, AIR WAS NO LONGER DRAWN IN. ALTHOUGH NO APPARENT VALVE DAMAGE COULD BE OBSERVED VISUALLY, THE POSSIBILITY OF THE VALVE DAMAGE COULD NOT BE RULED OUT AND CONTINUOUS USE WAS CONCERNED, SO THE VIZIGO SHORT WAS REPLACED WITH ANOTHER NEW ONE. THE PROCEDURE WAS THEN CONTINUED AND COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. AFTER SEVERAL TIMES OF FLUSHING, AIR WAS NO LONGER DRAWN IN. AS THE POSSIBILITY OF THE VALVE DAMAGE COULD NOT BE RULED OUT AND CONTINUOUS USE WAS CONCERNED, THE VIZIGO SHORT WAS REPLACED WITH ANOTHER NEW ONE. NO AIR WAS INTRODUCED INTO THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178436 ↗
• MalfunctionMar 30, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A VIZIGO SHEATH AIR WAS MIXED IN AT THE HEMOSTATIC VALVE PART AND COULD NOT BE REMOVED. THIS ISSUE OCCURRED IMMEDIATELY AFTER THE SHEATH WAS INSERTED INTO THE PATIENT'S BODY. THERE WERE NO DAMAGES OR DISLODGMENTS NOTED WITH THE VALVE, HUB, OR BRIM CAP. AIR WAS OBSERVED IN THE TRANSPARENT SECTION LOCATED SLIGHTLY BEYOND THE HEMOSTATIC VALVE OF THE SHEATH. THE PHYSICIAN ATTEMPTED TO ASPIRATE IT FROM THE SIDE PORT, BUT IT WAS UNSUCCESSFUL, SO THE SHEATH WAS REPLACED. NO AIR ENTERED THE PATIENT'S BODY. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716647 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND A BLOOD LEAK FROM THE HEMOSTATIC VALVE OCCURRED. DURING THE FIRST INSERTION OF THE VIZIGO SHORT, THERE WAS REVERSE BLOOD FROM THE HEMOSTATIC VALVE. THE VALVE WAS NOT BROKEN/CRACKED OR TOTALLY SEPARATED. THE HEMOSTATIC VALVE WAS NOT DISLODGED INSIDE OR OUTSIDE OF THE HUB AND THE BRIM CAP/HUB DID NOT DETACH FROM THE SHEATH. THE ISSUE OCCURRED WHILE THE DEVICE WAS BEING USED ON THE PATIENT BUT NO AIR ENTERED THE PATIENT¿S BODY. BLOOD LOSS WAS A FEW DROPS. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678158 ↗
• MalfunctionMar 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THE HEMOSTATIC VALVE BECAME DISLODGED. THIS OCCURRED ONE HOUR AFTER THE CATHETER USE, AT THE TIME OF REPLACEMENT. THE SHEATH HAD BEEN USED ON THE PATIENT. NO AIR ENTERED THE PATIENT'S BODY. NO BLOOD RETURN WAS OBSERVED. THE SHEATH WAS REPLACED AND THE REMAINDER OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607165 ↗
• MalfunctionJan 20, 2026Backflow; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND AIR WAS FOUND DURING ASPIRATION FROM THE SIDE PORT. ONE HOUR AFTER THE START OF USE, DAMAGE TO THE HEMOSTATIC VALVE WAS CONFIRMED. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 16-DEC-2025. THE SPECIFIC SECTION THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN OBSERVED. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2025. AIR WAS FOUND DURING ASPIRATION FROM SIDE PORT. WE COULD NOT GET THE DETAILED INFORMATION ON THE DEFECT. THE BRIM CAP AND THE HUB DID NOT DETACH FROM THE SHEATH. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 23-DEC-2025 THAT AIR WAS FOUND DURING ASPIRATION FROM THE SIDE PORT AND HAVE ASSESSED THIS ISSUE AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 23-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118380 ↗
• MalfunctionJan 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THE HEMOSTATIC VALVE WAS DAMAGED WHILE INSERTING THE SMARTTOUCH SF CATHETER INTO THE SHEATH. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 5-DEC-2025. THE SHEATH WAS BEING USED ON THE PATIENT; NO AIR ENTERED THE PATIENT¿S BODY, AND NO BLOOD RETURN WAS OBSERVED. THIS EVENT REMAINED NOT MDR REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 14-DEC-2025. THE HEMOSTASIS VALVE DISLODGED INSIDE OF THE HUB. THIS IS NOW MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028038 ↗
• MalfunctionDec 23, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A VIZIGO SHEATH AND A SIGNIFICANT AMOUNT OF AIR WAS DRAWN FROM THE SIDE PORT. AFTER THE OPTRELL WAS REMOVED FROM THE VIZIGO SHORT, AND THE QDOT MICRO CATHETER WAS INSERTED INTO THE VIZIGO SHORT, THE ISSUE OCCURRED WHILE AIR WAS BEING DRAWN. NO AIR WAS INTRODUCED INTO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE HEMOSTATIC VALVE WAS NOT DAMAGED. AFTER THAT, AIR WAS FULLY REMOVED. THE SHEATH WAS USED CAREFULLY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874946 ↗
• MalfunctionDec 17, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH AND AIR WAS CONFIRMED INSIDE OF THE SIDE TUBE AND THE PORT WITH THE HEMOSTATIC VALVE. EVERY TIME THE CATHETER WAS INSERTED, A LARGE AMOUNT OF AIR WAS DRAWN INTO THE VIZIGO SHEATH. TIMING WAS AFTER THE BROCKENBROUGH. THE ISSUE BEGAN AND CONTINUED SINCE THE VARIPULSE CATHETER WAS ADVANCED THROUGH THE VIZIGO SHEATH. ALTHOUGH AIR WAS DRAWN INTO THE SHEATH EACH TIME THE CATHETER WAS SWITCHED, AIR WAS ASPIRATED WITH METICULOUS CARE, AND THE VIZIGO SHEATH WAS USED AS IT WAS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-NOV-2025. AIR WAS CONFIRMED INSIDE OF THE SIDE TUBE AND THE PORT WITH HEMOSTATIC VALVE OF THE VIZIGO SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 01-DEC-2025. AIR WAS NOT INTRODUCED INTO THE PATIENT. AIR WAS METICULOUSLY ASPIRATED. THE SHEATH WAS USED UNTIL THE END OF THE PROCEDURE WITHOUT BEING REPLACED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-DEC-2025. THE FKD RF NEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825832 ↗
• MalfunctionDec 16, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND AIR WAS DRAWN FROM THE SHEATH AFTER INSERTING THE OCTARAY CATHETER. TO PERFORM ADDITIONAL ABLATIONS, THE SHEATH WAS REPLACED WHEN RE-INSERTING THE VARIPULSE CATHETER. NO HEMOSTATIC VALVE DAMAGE WAS NOTICED ON THE REPLACED SHEATH. THE PROCEDURE CONTINUED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821384 ↗
• MalfunctionDec 4, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED THAT REMOVING AIR WAS NOT EASILY ACCOMPLISHED. THE PHYSICIAN NOTED THAT REMOVING THE AIR WAS NOT EASILY ACCOMPLISHED. TIMING WAS DURING PRE-INSERTION PREPARATION. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR WAS BEING INTRODUCED INTO THE PATIENT. THE PHYSICIAN ATTEMPTED TO VENT THE AIR FROM THE SHEATH, BUT IT DID NOT WORK WELL, SO THE SHEATH WAS REPLACED WITH ANOTHER NEW ONE. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717176 ↗
• MalfunctionNov 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE BRIM CAP WAS DETACHED FROM THE DEVICE AND THE SILICON RING AND HEMOSTATIC VALVE WERE DETACHED. THE SILICON RING AND HEMOSTATIC VALVE COMPONENTS WERE NOT RETURNED TO BWI. DURING THE PROCEDURE, THE PARTS OF THE INSERTING PORT FOR THE CATHETER OF THE VIZIGO SHORT HAD AN ISSUE--THE OPTRELL CATHETER COULD NOT BE INSERTED INTO THE SHEATH. THIS OCCURRED OVER TWO HOURS INTO THE DEVICE'S FIRST USE. NO VISIBLE DAMAGES OR DISLODGMENTS WERE NOTED TO THE HEMOSTATIC VALVE, BRIM CAP, OR HUB AT THE TIME. NO AIR ENTERED THE PATIENT'S BODY. THE ISSUE WAS HANDLED BY REPLACING THE SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659215 ↗
• MalfunctionNov 25, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND AT THE TIME OF PUNCTURE. AIR WAS DRAWN FROM THE VIZIGO. AIR WAS DETECTED ONLY AT THE SIDE PORT. NO AIR ENTERED THE PATIENT¿S BODY. THE ISSUE WAS RESOLVED BY REPLACING VIZIGO SHORT WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653430 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND A VIZIGO SHEATH AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE, THORACOTOMY AND PROLONGED HOSPITALIZATION. DURING THE PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTION (PVC) ORIGINATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), WHILE MANEUVERING THE THERMOCOOL SMARTTOUCH SF CATHETER, A CARDIAC TAMPONADE OCCURRED. THE EVENT OCCURRED WHILE EXPLORING AFTER THE CATHETER WAS INSERTED FROM THE RIGHT ATRIUM (RA) INTO THE RIGHT VENTRICLE (RV). DRAINAGE WAS PERFORMED, AND THE PATIENT¿S VITALS IMPROVED. THE REST OF THE PROCEDURE WAS PERFORMED USING ABLAZE CATHETER (JAPAN LIFELINE). NO EXTENDED HOSPITALIZATION. THE RELATIONSHIP WITH THE PRODUCT WAS CAUSAL. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT WHEN ATTEMPTING TO ACCESS THE RVOT WITH THE VIZIGO SHEATH AND THE THERMOCOOL SMARTTOUCH SF CATHETER, CARDIAC TAMPONADE MIGHT HAVE OCCURRED AT THE LESION WHERE THE CONTACT FORCE BECAME HIGH. THE COLORING SETTING FOR VISITAG WAS TAG INDEX. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF TH

  Patient problems: Cardiac Tamponade

  MAUDE report 23646164 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND A HEMOSTATIC VALVE LEAKAGE ISSUE WAS OBSERVED. INITIALLY IT WAS REPORTED THAT THE VALVE OF THE VIZIGO SHORT WAS DEFECTIVE. TIMING WAS AFTER THE SHEATH WAS INSERTED AND WHEN THE CATHETER WAS INSERTED. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 05-OCT-2025. THE SECTION THAT THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN WAS OBSERVED. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 23-OCT-2025. THE SECTION THAT THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE AND THE ISSUE WAS LEAKAGE. THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB NOR OUTSIDE OF THE HUB. THE BRIM CAP / HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE HEMOSTATIC VALVE DEFECTIVE ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE; HOWEVER, BWI BECAME AWARE ON 23-OCT-2025 OF A LEAKAGE ISSUE WITH THE HEMOSTATIC VALVE AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563292 ↗
• MalfunctionOct 30, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHORT SHEATH - MEDIUM AND AIR WAS DRAWN INTO THE DEVICE. THIS OCCURRED WHEN REMOVING THE VARIPULSE CATHETER AND INSERTING AN OCTARAY. THE HEMOSTATIC VALVE OF THE VIZIGO SHORT ITSELF WAS NOT DAMAGED. NO AIR ENTERED THE PATIENT'S BODY. THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427253 ↗
• MalfunctionOct 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A VIZIGO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT BEFORE INSERTING INTO THE PATIENT¿S BODY, AT THE TIME OF PUNCTURE, THE VALVE WAS TIGHT, THE DILATOR COULD NOT BE INSERTED. THE ISSUE WAS RESOLVE BY REPLACING WITH ANOTHER NEW VIZIGO. THERE WAS NO DAMAGE TO THE SHEATH, THERE WAS NO OCCLUSION AND NO MATERIAL CAUSING AN OBSTRUCTION. THE CUSTOMER'S REPORTED IMPEDED ENTRY ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319451 ↗
• InjurySep 11, 2025Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A VIZIGO SHEATH AND THE PATIENT EXPERIENCED AIR EMBOLISM / ST ELEVATION / CARDIAC ARREST THAT REQUIRED MEDICATION AND CPR. IT WAS REPORTED THAT THE PATIENT HAD AN AIR EMBOLISM DURING THE PROCEDURE. ST ELEVATION WAS FIRST NOTICED ON THE NURSE'S SIGNALS AND THEN WAS CONFIRMED ON THE 12-LEAD SIGNALS DISPLAYED ON THE CARTO 3 SYSTEM. THE PATIENT WAS NOT IN FULL CARDIAC ARREST AND THAT THERE WAS SMALL MOVEMENT IN THE RIGHT VENTRICLE; HOWEVER, THE PATIENT'S HEART RATE WAS LOW AND THE PATIENT'S BLOOD PRESSURE WAS DROPPING. THE MEDICAL INTERVENTION PROVIDED WAS CPR ON THE TABLE. AFTER CPR WAS PERFORMED, THE PATIENT'S SIGNAL "KIND OF" LEVELED OUT AND THE ST ELEVATION WENT DOWN. THE PATIENT'S BLOOD PRESSURE ROTATED FROM STABLE TO UNSTABLE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED WHILE THE PATIENT WAS STILL ON THE TABLE AND IT SHOWED A SIGN OF "AN ANEURISM". THE PATIENT WAS STABLE ENOUGH TO MOVE INTO ANOTHER ROOM WHERE A HEART CATH WAS USED TO CONFIRM THE AIR EMBOLISM IN THE LEFT ATRIUM. THE PATIENT WAS UP, AWAKE, AND MOVING ALL EXTREMITIES. THE LAST KNOWN PATIENT STATUS WAS STABLE. NO ABLATION HAD BEEN PERFO

  Patient problems: Air Embolism; Cardiac Arrest; Ischemic Heart Disease; Low Blood Pressure/ Hypotension

  MAUDE report 23023720 ↗
• MalfunctionAug 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND HEMOSTATIC VALVE BROKE. APPROXIMATELY 2 HOURS AFTER THE VIZIGO SHORT WAS USED, THE HEMOSTATIC VALVE WAS MALFUNCTIONING. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHORT TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. ON 4-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE HEMOSTATIC VALVE WAS BROKEN/CRACKED. THE HEMOSTATIC VALE WAS NOT DISLODGED INSIDE OR OUTSIDE THE HUB AND THE BRIM CAP DID NOT BECOME DETACHED FROM THE SHEATH. NO AIR ENTERED THE PATIENT¿S BODY AND NO BLOOD RETURN WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920039 ↗
• InjuryAug 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH VARIPULSE CATHETER AND A VIZIGO AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH DRAINAGE AND REMOVAL OF 750ML OF FLUID. IT WAS REPORTED THAT APPROXIMATELY 20 MINUTES OF USE OF THE VARIPULSE CATHETER, A MAGNETIC SENSOR ERROR OCCURRED AND ABLATION WAS NOT POSSIBLE WITH VARIPULSE CABLE. THE ISSUE RESOLVED BY REPLACING THE CATHETER AND CABLE. THE CUSTOMER'S REPORTED MAGNETIC SENSOR ERROR WITH THE VARIPULSE CATHETER AND CABLE ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. IT WAS ALSO REPORTED A CARDIAC TAMPONADE WAS DISCOVERED AFTER THE ABLATION PROCEDURE. PERICARDIAL EFFUSION CONFIRMED WITH ECHOCARDIOGRAPHY, AND A BLOOD PRESSURE DECREASE NOTED. DRAINAGE PERFORMED, AND OVER 750 ML OF FLUID DRAWN. THE PATIENT LEFT THE ROOM. THE PHYSICIAN¿S ASSESSMENT REGARDING THE HEALTH HAZARD WAS THAT IT WAS NOT SERIOUS (MODERATE/MINOR). THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. CAUSAL RELATIONSHIP WITH THE PRODUCT WAS NOTED. THE PHYSICIAN¿S COMMENTED ON THE RELATIONSHIP BETWEEN THE EVE

  Patient problems: Cardiac Tamponade

  MAUDE report 22900974 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A VIZIGO AND WHEN INSERTING THE DILATOR, BEFORE INSERTING INTO INTRACARDIAC, THE HEMOSTATIC VALVE WAS BROKEN. THE VIZIGO SHEATH WAS REPLACED WITH A SHEATH FROM ANOTHER COMPANY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869547 ↗
• MalfunctionAug 20, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO. AFTER BROCKENBROUGH (BB) WITH THE VIZIGO SHEATH, THE VIZIGO SHEATH COULD NOT BE INSERTED IN THE LEFT ATRIUM (LA). WHEN THE SHEATH WAS REMOVED FROM THE CARDIAC CAVITY, THE TIP OF THE SHEATH WAS FOUND TO BE DENTED. RESOLVED BY REPLACING THE SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ISSUE OF THE VIZIGO SHEATH COULD NOT BE INSERTED IN THE LA WITH THE TIP FOUND TO BE DENTED WAS ASSESSED AS MDR REPORTABLE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 21-JUL-2025 REVEALED A PERFORATION ON THE TIP OF THE VIZIGO SHEATH. THE BWI PRODUCT ANALYSIS LAB BECAME AWARE OF THE A PERFORATION ON THE TIP OF THE VIZIGO SHEATH ON 21-JUL-2025 AND HAVE ALSO ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855923 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED THE HEMOSTATIC VALVE BROKEN/CRACKED. THE VALVE PART WAS DAMAGED WHEN INSERTING THE CATHETER. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHEATH TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 24-JUL-2025. THE SECTION WHERE THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE. THIS PART WAS BROKEN/CRACKED. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN WAS OBSERVED. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 24-JUL-2025 OF THAT THE HEMOSTATIC VALVE WAS BROKEN/CRACKED AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 24-JUL-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805558 ↗
• MalfunctionAug 13, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH. AFTER PUNCTURE OF FEMORAL SITE, WHEN INSERTING THE WIRE, IT GOT STUCK IN THE DILATOR AND COULD NOT BE REMOVED. THERE WAS NO ERROR CODE. THE ISSUE WAS RESOLVED BY REPLACING VIZIGO SHEATH WITH ANOTHER NEW ONE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800133 ↗
• MalfunctionAug 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED THE HEMOSTATIC VALVE BROKEN/CRACKED. DEFECTIVE HEMOSTATIC VALVE. CONFIRMED UPON INSERTING THE CATHETER INTO THE SHEATH. REPLACED THE VIZIGO SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 24-JUL-2025. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 28-JUL-2025. THE HEMOSTATIC VALVE WAS BROKEN/CRACKED. THE HEMOSTATIC VALVE WAS NOT DISLODGED INSIDE THE SHEATH NOR OUTSIDE THE SHEATH. THE BRIM CAP / HUB DID NOT BECOME DETACHED. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN WAS OBSERVED. NO NEEDLE WAS INVOLVED IN THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783516 ↗

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-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
• 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-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