Use cautionMedical device recall · FDA · Published June 29, 2022
Biosense Webster CARTO VIZIGO 8.5F Sheath Recall: Water Damage Risk of Infection
Biosense Webster recalls CARTO VIZIGO 8.:5F Bi-Directional Guiding Sheaths with water damage risk. Compromised sterile barrier may cause infection. Affected units have specific UDI-DI and lot numbers.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Take action
Contact the company
📍Recalling firmBiosense Webster, Inc.15715 Arrow Hwy · Irwindale, CA 91706-2006
“Biosense Webster CARTO VIZIGO 8.5F Sheath Recall: Water Damage Risk of Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60412-biosense-webster-carto-vizigo-8-5f-sheath-recall-water-damage. Based on FDA recall #Z-1677-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1677-2022%22&limit=1).
The FDA announced on June 29, 2022, that Biosense Webster, Inc. is recalling the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath due to water damage that may compromise the sterile barrier. The agency stated the recall is voluntary and ongoing.
The FDA said the outside packaging for the device indicated for introducing cardiovascular catheters into the heart sustained water damage. This damage may have affected the sterile barrier of the product inside, potentially making devices with a compromised sterile barrier a source for infection.
Context
GovInfoNow's records show Biosense Webster, Inc. has had 7 other recalls on record since June 14, 2017. Other recent recalls of similar products include the Stryker BW Webster Duo-Decapolar Catheter Recall (April 10, 2026) and the Sheathes3D Viral Barrier Ultrasound Probe Covers Recall (Nov. 17, 2025).
How to tell if you have this one
Check for the UDI-DI number 10846835016253 and lot number 00002001 on the sheath packaging. The sheath is used to introduce cardiovascular catheters into the heart.
Brand
Biosense Webster
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging
Look for the UDI-DI number 10846835016253 and lot number 00002001 on the sheath packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Georgia, Indiana, Iowa, Maine, Massachusetts, New Hampshire, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates potential water damage that could compromise the sterile barrier, so it is not safe to use without checking the packaging details.
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-1677-2022 (June 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1677-2022 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.