Recall record at a glance
| Official record | Z-1290-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Biosense Webster, Inc. |
| Report date | Mar 20, 2024 |
| Recall initiation date | Feb 16, 2024 |
| Quantity | 853 units |
| Location | Irvine, CA, United States |
Official product description
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 anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180 and counterclockwise = 180. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.
Why the product was recalled
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.