Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath Due to Manufacturing
Biosense Webster recalls CARTO VIZIGO Bi-Directional Guiding Sheath (REF D128502) produced with a manufacturing mix-up during validation. Affected units may have been inadvertently mixed into main production. Contact for remedy details.
Lower-risk recall
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Contact the company
What happened, in plain English
Biosense Webster is recalling a specific model of cardiac sheath due to a manufacturing issue where units were accidentally mixed into production during validation. This could lead to potential safety risks if the sheath is used improperly. Read more at govinfonow.com/recall/56147-biosense-webster-recalls-carto-vizigo-bi-directional-guiding-sheath-due.
Source Summary by GovInfoNow · govinfonow.com/recall/56147-biosense-webster-recalls-carto-vizigo-bi-directional-guiding-sheath-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1290-2024
Cite this page
“Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath Due to Manufacturing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56147-biosense-webster-recalls-carto-vizigo-bi-directional-guiding-sheath-due. Based on FDA recall #Z-1290-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1290-2024%22&limit=1).
Why it’s dangerous
The sheath was produced with a manufacturing mix-up during the validation phase, meaning some units were inadvertently mixed into the main production process. This could result in units that do not meet the required safety standards for cardiac procedures.
Who’s affected
Medical professionals using the CARTO VIZIGO Bi-Directional Guiding Sheath for cardiac procedures are most at risk. Patients undergoing these procedures may be affected if the sheath is used without proper validation.
How to tell if you have this one
Check for the product reference number D128502 on the sheath. Affected units were produced with lot numbers 60000282. The sheath is used in cardiac procedures and has specific features like a hemostasis valve and radiopaque tip marker.
- Brand
Biosense Webster- Category
Medical device
What to do — step by step
Check Product Details
Look for the product reference number D128:502 and lot number 60000282 on the sheath.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 41 states.
FDA distribution: “U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1290-2024 (February 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1290-2024 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.