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Use caution Medical device recall · FDA · Published February 26, 2021

Biosense Webster CARTO VIZIGO Sheath Recall: Risk of minor bleeding or embolism

Biosense Webster recalls specific cardiac sheaths for potential minor bleeding or embolism if the hemostatic valve dislodges during use. Affected models include 8. 5F (Large) C3, REF: D138503.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1286-2021Medical deviceBiosense Webster ›
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Contact the company

Recalling firmBiosense Webster, Inc.15715 Arrow Hwy · Irwindale, CA 91706-2006
✎ GovInfoNow plain-language explainer

Biosense Webster is recalling a specific cardiac sheath used in heart procedures due to a risk that the hemostatic valve might dislodge, causing minor bleeding or embolism. This is a serious hazard for medical professionals during procedures. Read more at govinfonow.com/recall/63184-biosense-webster-carto-vizigo-sheath-recall-risk-of-minor-bleeding.

Source Summary by GovInfoNow · govinfonow.com/recall/63184-biosense-webster-carto-vizigo-sheath-recall-risk-of-minor-bleeding · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1286-2021

Cite this page

“Biosense Webster CARTO VIZIGO Sheath Recall: Risk of minor bleeding or embolism.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63184-biosense-webster-carto-vizigo-sheath-recall-risk-of-minor-bleeding. Based on FDA recall #Z-1286-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1286-2021%22&limit=1).

Biosense Webster, Inc. recalled the CARTO VIZIGO Bi-Directional Guiding Sheath due to a potential hemostatic valve dislodgement hazard that could cause bleeding or embolism, according to the FDA on Feb. 26, 2021.

How to tell if you have it

  • Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE
  • UPC 10846835016260

The hazard

The hemostatic valve may dislodge when introducing a dilator or device into the sheath. This defect could result in minor bleeding and/or embolism.

Context

GovInfoNow's records show Biosense Webster, Inc. has had 7 other recalls on record since June 14, 2017. Recent brand recalls include the Jan. 5, 2025 VARIPULSE Catheter Recall for neurovascular event risk and the Feb. 16, 2024 CARTO VIZIGO Bi-Directional Guiding Sheath recall due to a manufacturing mix-up. Other recent recalls of similar products include the June 11, 2026 Boston Scientific FARADRIVE Steerable Sheath Recall for risk of air embolism and the June 11, 2026 Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall for risk of air embolism from valve damage.

How to tell if you have this one

Check for the model name 'CARTO VIZIGO', size '8.5F (Large) C3', and reference number 'D138503'. The product is sterile and used only with a prescription for cardiac procedures.

  • Brand
    Biosense Webster
  • Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Completed
  • Distribution
    Worldwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1285-2021Biosense 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 accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.; All Lots71,473 units
Z-1286-2021Biosense 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 accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.; All LotsN/A
Z-1287-2021Biosense 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 accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.; All LotsN/A
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model, size, and reference number to confirm if your sheath is affected.

How this recall unfolded

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Feb 26, 202112. FDA classified it Class II: Mar 22, 202123. Published in FDA’s Enforcement Report: Mar 31, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1286-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1286-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA