VIZIGO D138503Recalls & reported problems

Summary

The FDA's MAUDE database contains 362 adverse event reports that list this exact device (DI 10846835016260), received between Dec 21, 2018 and Sep 24, 2026 — classified as 10 injuries, 352 malfunctions.

The most frequently reported specific device problem is “Material Separation” (142 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 362 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VIZIGO and the hemostatic valve was broken.It was reported that at the time of catheter insertion after puncture, resistance was felt during catheter insertion, possibly because part of the hemostatic valve was broken. Additional information received indicating the hemostatic valve was not dislodged inside or outside of the hub and the brim cap/hub did not detach from the sheath. There was no patient consequence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876782 ↗
• MalfunctionMay 26, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA - (IDVT) PROCEDURE WITH A VIZIGO SHEATH. THEY WERE ATTEMPTING TO GO TRANSSEPTAL, THE VIZIGO SHEATH WAS INTRODUCED AND IT FOLDED BACK ON ITSELF. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295430 ↗
• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THE HEMOSTATIC VALVE DISLODGED ISSUE WAS OBSERVED. AFTER THE OPTRELL HAD BEEN USED FOR TWO HOURS, UPON REMOVING IT FROM THE VIZIGO SHEATH AND SWITCHING TO THE ABLATION CATHETER, THE VALVE WAS DAMAGED. THE HEMOSTATIC VALVE WAS DISLODGED INTO THE HUB. THE HEMOSTATIC VALVE ITSELF WAS INTACT. TIMING WAS AFTER THREE HOURS OF USE, AT THE TIME OPTRELL WAS REMOVED. THE ISSUE WAS ADDRESSED BY REPLACING THE VIZIGO SHEATH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074624 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED THE VALVE ON THE BACK LEAKING AND BLOOD BACKFLOW. AFTER THE VIZIGO SHEATH WENT TRANSSEPTAL, THE VALVE ON THE BACK WAS LEAKING AND THERE WAS A BLOOD BACKFLOW. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. UNSURE IF THE HEMOSTATIC VALVE DISLODGED INSIDE THE HUB. UNSURE IF THE HEMOSTATIC VALVE DISLODGED OUTSIDE THE HUB. THE BRIM CAP DID NOT BECOME DETACHED FROM THE SHEATH. THE HUB DID NOT BECOME DETACHED FROM THE SHEATH. AIR ENTERED THE PATIENT¿S BODY. LESS THAN 10CC¿S OF BLOOD LOSS. DID NOT REQUIRE TREATMENT. NO PATIENT CONSEQUENCE. IT WAS REPORTED THAT AIR ENTERED THE PATIENT; HOWEVER, THERE WERE NO PATIENT CONSEQUENCES AND NO TREATMENT REQUIRED. SINCE THE PATIENT WAS ASYMPTOMATIC (AS IMPLIED) AND THE AIR WAS NOTICED AS AN OBSERVATION, DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION, THERE WAS NO REPORT OF PERMANENT IMPAIRMENT, NO REPORT OF RADIOGRAPHIC EVIDENCE OF INFARCTION, AND NO REPORT OF EXTENDED HOSPITALIZATION WAS REPORTED, THIS I

  Patient problems: Air Embolism

  MAUDE report 24866125 ↗
• MalfunctionApr 1, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND AFTER THE CATHETER WAS REMOVED FROM FLUSHING, AIR WAS DRAWN INTO THE HEMOSTATIC VALVE. THE CATHETER WAS REINSERTED BUT THE VALVE OF THE SHEATH DID NOT SEEM TO CLOSE ALL THE WAY ANYMORE. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761031 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH. THERE WAS A BACKFILL OF BLOOD ON THE IRRIGATION PORT FOR THE VIZIGO SHEATH NOTICED AT THE END OF THE CASE. THE VIZIGO SHEATH WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED. THE NGEN AND TRUPULSE SYSTEMS WERE USED FOR ABLATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694879 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AFTER SHEATH INSERTION, THE HEMOSTATIC VALVE WAS FOUND DEFECTIVE, AND BLOOD WAS LEAKING FROM THE HEMOSTATIC VALVE. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT AND NO AIR ENTERED THE PATIENT¿S BODY. BLOOD RETURN WAS OBSERVED, A FEW DROPS, BUT 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 24511200 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A VIZIGO SHEATH AND SLIGHT BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE WAS OBSERVED. THE REPORT INDICATED THAT WHEN INSERTING THE VIZIGO INTO THE PATIENT, THE DOCTOR COMMENTED THAT SLIGHT BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE COULD BE OBSERVED. IT OCCURRED WITHIN TEN MINUTES AFTER THE SHEATH WAS USED. WHEN A CATHETER WAS INSERTED INTO THE SHEATH, THE REPORTED SHEATH WAS FLUSHED; HOWEVER, NO AIR COULD BE CONFIRMED. THEREFORE, THE PHYSICIAN DECIDED TO USE THE SHEATH CONTINUOUSLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED SHEATH. THE HEMOSTATIC VALVE ITSELF WAS NOT OBVIOUSLY BROKEN/CRACKED VISUALLY. ADDITIONAL INFORMATION INDICATED THAT THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY AND BLOOD RETURN WAS OBSERVED. A FEW DROPS OF BLOOD WERE LOST; 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 24381789 ↗
• MalfunctionFeb 4, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND WHEN THE CATHETER WAS INSERTED INTO THE VIZIGO SHEATH, AIR ENTERED FROM THE THREE-WAY STOPCOCK. AIR ENTRY WAS PREVENTED BY CLAMPING THE SIDE PORT WITH FORCEPS. THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255484 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  THE PATIENT UNDERWENT INDEX ABLATION PROCEDURE WITH A VIZIGO THE PATIENT EXPERIENCED POSTINTERVENTIONAL ANEURYSMAL SPURIUM AT THE RIGHT GROIN. ON (B)(6) 2025, THE ADVERSE EVENT START DATE, THE PATIENT EXPERIENCED POSTINTERVENTIONAL ANEURYSMAL SPURIUM AT THE RIGHT GROIN (ADVERSE EVENT # 1) CATEGORIZED AS MODERATE AND NOT SERIOUS. THE RELATIONSHIP TO THE STUDY DEVICE OF QDOT MICRO CATHETER WAS CLASSIFIED AS NOT RELATED. THE RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS CONSIDERED CAUSAL. THE PATIENT¿S OUTCOME WAS REPORTED AS RESOLVED WITH AN END DATE ON (B)(6) 2025. INTERVENTION WAS OTHER THROMBIN INJECTION.

  Patient problems: Pseudoaneurysm

  MAUDE report 24016144 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THE VALVE WAS 'TOO TIGHT' AND ALSO LEAKED. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007091 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND THERE WAS BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE. IT WAS REPORTED BY THE CUSTOMER THAT BLOOD LEAKED FROM THE HEMOSTATIC VALVE OF THE VIZIGO SHEATH. THEREFORE, THE SHEATH WAS REPLACED WITH ANOTHER NEW ONE. THE PHYSICIAN COMMENTED THAT THE CAUSE OF THE BLOOD LEAKAGE MIGHT HAVE RESULTED FROM REPEATEDLY REMOVING AND REINSERTING THE OPTRELL WHILE IT WAS INSIDE THE VIZIGO SHEATH. ADDITIONAL INFORMATION RECEIVED INDICATING 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. THE BLOOD LOSS WAS A FEW DROPS, BUT THE EXACT AMOUNT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796358 ↗
• MalfunctionDec 11, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND A CLEAR, STRINGY, FIBROUS PART OF THE OPTRELL CAME OUT OF THE SHEATH. IT WAS REPORTED THAT WHEN THE OPTRELL WAS REMOVED FROM THE VIZIGO SHEATH, A CLEAR, STRINGY, FIBROUS PART OF THE OPTRELL CAME OUT OF THE SHEATH. THERE WAS NO PHYSICAL DAMAGE NOTICED ON THE OPTRELL CATHETER. A PRE-SHAPED NEEDLE WAS USED. THE PHYSICIAN WAS FINISHED WITH THE OPTRELL AT THAT TIME BUT REPLACED THE VIZIGO SHEATH OUT OF AN ABUNDANCE OF CAUTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777584 ↗
• MalfunctionDec 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND WHEN THE MEDICAL TEAM OPENED THE VIZIGO SHEATH PACKAGING, THE MEDICAL TEAM NOTED A WHITE PLASTIC SUBSTANCE INSIDE OF THE VALVE. THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771778 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE AND THE VIZIGO® SHEATH WAS LEAKING BACK BLOOD. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE EXCHANGING CATHETERS, IT WAS NOTICED THAT THE HEMOSTATIC VALVE ON THE VIZIGO® SHEATH WAS LEAKING BACK BLOOD. THE VIZIGO® SHEATH WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713252 ↗
• MalfunctionOct 27, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THE TIP OF SHEATH FLIPPED OUTWARD. WHEN INSERTED INTO THE PATIENT'S BODY. WHEN THE SHEATH PASSED THROUGH THE ATRIAL SEPTUM, THE TIP WAS WRINKLED. NO CRACKS OR SPLITS WERE NOTED. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388687 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A VIZIGO AND THE PHYSICIAN POINTED OUT THAT REVERSE BLOOD FROM THE SUCTIONING PORT OF THE VIZIGO SHEATH COULD NOT BE STOPPED. IT OCCURRED AFTER THE BROCKENBROUGH. THE ISSUE WAS IMPROVED BY REPLACING THE VIZIGO SHEATH WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. BLOOD RETURN WAS OBSERVED AND A FEW DROPS OF BLOOD WAS LOST, BUT THE EXACT AMOUNT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375839 ↗
• MalfunctionAug 27, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR BUBBLES WERE VISUALLY CONFIRMED TO FLOW INTO THE SIDE PORT SIDE AND LEAKAGE WAS NOTED IN THE HEMOSTATIC VALVE. AFTER REMOVING THE VARIPULSE CATHETER FROM THE VIZIGO SHEATH, AIR BUBBLES FLOWED IN FROM THE HEMOSTATIC VALVE OF THE VIZIGO SHEATH. THE VIZIGO SHEATH WAS REPLACED WITH AGILIS. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT WHEN SUCTION WAS PERFORMED USING A SYRINGE THROUGH THE SIDE PORT, BLOOD WAS ASPIRATED FROM THE SHEATH MAIN BODY SIDE, AND A SMALL AMOUNT OF AIR BUBBLES WERE VISUALLY CONFIRMED TO FLOW INTO THE SIDE PORT SIDE FROM THE HUB SIDE. THE AIR BUBBLES WERE NOT FLOWING INTO THE SHEATH MAIN BODY SIDE. IT WAS ALSO INDICATED THAT LEAKAGE WAS NOTED IN THE HEMOSTATIC VALVE. THE HEMOSTASIS VALVE (GASKET) DID NOT DISLODGE INSIDE, NOR OUTSIDE THE HUB. THE BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT, NO AIR ENTERED THE PATIENT¿S BODY, AND NO BLOOD RETURN WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908244 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED BLOOD BACK FLOW AT THE HEMOSTATIC VALVE. THE PATIENT WAS ON THE TABLE FOR AN VT ABLATION. THE PHYSICIAN WAS MAPPING THE LEFT VENTRICLE (LV) WITH THE SMARTTOUCH CATHETER. HE REALIZED THAT THE VIZIGO SHEATH HAD A BACK FLOW AT THE VALVE. HE REMOVED THE CATHETER. THE VIZIGO SHEATH WAS IRRIGATED AT 100CC. H (NACL0.9%). THERE WAS BLOOD BACK FLOW. THE PHYSICIAN REMOVED BLOOD WITH A SYRINGE. WHEN IRRIGATION WENT BACK, BACK FLOW OF SALINE WAS OBSERVED. WHITE VALVE IN THE VIZIGO SHEATH TUBE WAS VISUALIZED AND LOOKED IN THE RIGHT PLACE. NO ISSUE HAPPENED AT THE BEGINNING OF THE PROCEDURE, WHEN THE NURSE PREPARED THE MATERIAL. THE INNER HAS BEEN PLACED EASILY IN THE SHEATH. THE PHYSICIAN REPLACED THE SHEATH BY AN AGILIS L SHEATH. THERE WAS NO OTHER VIZIGO SHEATH. THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUL-2025. THE SECTION WHERE THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE. THE HEMOSTATIC VALVE WAS NOT DISLODGED; SEEMED IN PLACE. THE BRIM CAP / HUB DID NOT BECOME DETAC

  Patient problems: Air Embolism

  MAUDE report 22856450 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND THE SIDEPORT WAS BROKEN. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE IRRIGATION TUBING FROM THE VIZIGO WAS PHYSICALLY DAMAGED. THEY CHANGED THE VIZIGO AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED AND NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SIDE PORT WAS BROKEN/CRACKED. NO AIR ENTERED THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755193 ↗
• MalfunctionJun 10, 2025Material Separation; Material Separation

  THE VALVE ON THE VIZIGO WAS BROKEN. THE VIZIGO WAS NOT USED ON THE PATIENT; NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179064 ↗
• MalfunctionJun 3, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THERE WAS AIR CONTAMINATION DUE TO A FAULTY VALVE ON THE VIZIGO SHEATH SIDE PORT. THE HEMOSTATIC VALVE WAS LOOSE. THIS OCCURRED AFTER INSERTING THE VIZIGO SHEATH AND DURING THE INSERTION OF THE OPTRELL INTO THE PATIENT¿S BODY. EVEN WITH NEGATIVE PRESSURE APPLIED, AIR DID NOT ESCAPE. NO DAMAGES OR DISLODGMENTS WERE NOTED ON THE BRIM CAP OR HUB. NO AIR ENTERED THE PATIENT'S BODY. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137495 ↗
• MalfunctionMay 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND A HEMOSTATIC VALVE LEAKAGE ISSUE WAS OBSERVED. THE HEMOSTATIC VALVE OF VIZIGO SHEATH WAS DAMAGED APPROXIMATELY 4 HOURS AFTER THE START OF THE PROCEDURE, WHEN THE OPTRELL CATHETER WAS INSERTED INTO THE PATIENT¿S BODY. SINCE THERE WAS ONLY ONE DEFLECTABLE SHEATH L-CURVE FOR LENDING, IT WAS REPLACED WITH AGILISL. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-APR-2025. 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 24-APR-2025. BLOOD LEAKAGE FROM THE VIZIGO HEMOSTATIC VALVE WAS FOUND. THE BRIM CAP / HUB DID NOT BECOME DETACHED FROM THE SHEATH. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 24-APR-2025 OF BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 24-APR-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046147 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT-SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THE DEVICE WAS VISIBLY DAMAGED DURING THE PROCEDURE. THE SHEATH WAS DAMAGED WHILE THE STSF CATHETER WAS BEING REMOVED. THE HEMOSTATIC VALVE DISLODGED FROM THE SHEATH. THE MEDICAL TEAM TRIED TO PUT THE VALVE BACK IN PLACE WITHOUT RESOLUTION. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007005 ↗
• MalfunctionMay 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A VIZIGO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE HEMOSTATIC VALVE TO BE DISLODGED INSIDE OF HUB COMPONENT. INITIALLY, IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, DURING SETTING, THE DILATOR COULD NOT ADVANCE INTO THE HEMOSTATIC VALVE AND COULD NOT BE INSERTED INTO THE VIZIGO SHEATH. THERE WAS NO DAMAGE ON SHEATH/DILATOR DUE TO THE OBSTRUCTED SHEATH AND THERE WAS NO OCCLUSION WHEN IRRIGATING THE SHEATH. WHEN THE SHEATH WAS REPLACED, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 10-APR-2025, THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 10-APR-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965520 ↗

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-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-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-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-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