Recall Z-1290-2024 ยท DYB Introducer, Catheter
Biosense Webster, Inc.
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
| Date | Mar 13, 2024 (initiated Feb 16, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. |
| Root cause | Under Investigation by firm |
| Action | On 02/16/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that Biosense Webster identified through a complaint investigation that a mix-up occurred during the manufacturing of two lots. The devices could potentially be shorter in length (24 1/8 inches (61.28 cm) instead of, 28 inches (71 cm). Customer are instructed/informed: If a CARTO VIZIGO" Bi-Directional Guiding Sheath, Medium Curve (Catalog Number: D-1385-02) from Lot Numbers 60000282 and 60000287 is being used in their facility, they should continue to follow the IFU. The Instruct |
| Quantity | 853 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc., Jul 25, 2017 |