VIZIGO D138502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,839 adverse event reports that list this exact device (DI 10846835016277), received between Jan 31, 2019 and Sep 30, 2026 — classified as 4 deaths, 110 injuries, 2,725 malfunctions.

The most frequently reported specific device problem is “Material Separation” (1,076 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 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 16, 2026.

Recalls naming this device

1. Feb 16, 2024Open, Classified

   Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

   Z-1290-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 21, 2023Open, Classified

   Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

   Z-1320-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,839 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949584 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940922 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921581 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917705 ↗
• MalfunctionSep 25, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905972 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that a patient underwent an Atrial Fibrillation (AFib) procedure with a VIZIGO sheath. When the VIZIGO sheath was in the Superior Vena Cava, the physician noticed there was blood bleed back in the hemostatic valve. The VIZIGO sheath was replaced and there were no issues with the replacement VIZIGO sheath. No patient consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898768 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation procedure with a VIZIGO sheath and the patient experienced vein perforation that required balloon deployment.The VIZIGO Sheath was transeptal and when changing to a Faradrive Sheath, the iliac vein was perforated. The patient was hypotensive. The VIZIGO wire was being used at that time. The vein was reported to have been stented (then reported that an aortic balloon was used to stop the bleed). No ablation was performed. Physician¿s opinion is that something during the sheath exchange causes the incident.

  Patient problems: Perforation of Vessels

  MAUDE report 50885025 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that a patient underwent a cardiac ablation procedure with a Vizigo sheath and the irrigation port appeared to be leaking when flushed during prep before the case. The medical team inspected the sheath and found that the end of the port was visually uneven and possibly cracked. When a syringe was inserted and flushed, fluid leaked out. No damages or dislodgments were noted on the hemostatic valve, brim cap, and hub. No significant surgical delay occurred. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879893 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778430 ↗
• MalfunctionSep 3, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592061 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak

  It was reported that while performing an Atrial Fibrillation (AFib) procedure with a VIZIGO and when the doctors were finishing mapping the left atrium, they removed the Octaray Catheter to switch to the Varipulse Catheter and they noticed a leak in the VIZIGO sheath valve. Consequently, the sheath was replaced to proceed with the rest of the procedure in order to prevent air bubbles from entering the left atrium. There was no patient consequence

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558572 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525586 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458114 ↗
• MalfunctionAug 24, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416955 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416357 ↗
• MalfunctionAug 20, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334805 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  It was reported that a ptaient underwent a cardiac ablation procedure with a Vizigo sheath and the medical team noted that the valve was leaking. There was no significant surgical delay as a result of this issue. No further details have been reported regarding troubleshooting of the device or completion of the procedure. Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201494 ↗
• InjuryAug 10, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a supraventricular tachycardia (SVT) ablation procedure on (b)(6)2026 with a NaviStar ThermoCool Catheter, VARIPULSE¿ Bi-Directional Catheter, and Vizigo Sheath, and on the following day the patient experienced pericarditis categorized as moderate and serious defined by hospitalization with an admission date of (b)(6)2026 and a discharge date of (b)(6)2026. Relationship to study devices (VARIPULSE, VIZIGO and NAVISTAR THERMOCOOL) is possible and relationship to the index study procedure is possible. The adverse event is anticipated. The outcome is resolved with an end date of (b)(6)2026. Intervention was medication (colchicine).There are three reports for this event for the NaviStar ThermoCool Catheter, VARIPULSE¿ Bi-Directional Catheter, and Vizigo Sheath. This report is for the Vizigo.

  Patient problems: Pericarditis

  MAUDE report 50200213 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147957 ↗
• MalfunctionAug 5, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137140 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136066 ↗
• MalfunctionJul 29, 2026Backflow; Fluid/Blood Leak; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072328 ↗
• MalfunctionJul 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857860 ↗
• MalfunctionJul 8, 2026Material Separation; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750994 ↗
• MalfunctionJul 6, 2026Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO SHEATH AND IT COULD NOT BE INSERTED DUE TO "PHYSICAL ANOMALIA". THE SHEATH HAD FOLDS AT THE TIP, WHICH DO NOT BELONG THERE. THEREFORE, IT WAS NOT POSSIBLE FOR THE DOCTOR TO ADVANCE THE SHEATH FROM THE RIGHT ATRIUM (RA) TO THE LEFT ATRIUM (LA) VIA THE SEPTUM. THERE WAS NO PROBLEM WITH VESSELS OR THE DILATOR. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25720955 ↗

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-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-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