Biosense Webster, Inc. Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
Lot # 00002137, UDI (GTIN) : 10846835016253
Products Sold
Lot # 00002137; UDI (GTIN) : 10846835016253
Biosense Webster, Inc. is recalling Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 279 due to Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Recommended Action
Per FDA guidance
On March 2, 2023, Biosense Webster, Inc. issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notification to affected US customers via FedEx. The notification was issued to foreign consignees on February 29, 2023. In addition to informing consignees about the recall Biosense Webster asked customer to take the following actions: 1. Carefully review the information contained in this Medical Device Correction/Removal. 2. Ensure that anyone in your facility who needs to be aware of this notification reads the attached letter carefully. 3. Evaluate if you have inventory of CARTO VIZIGO" Bi-Directional Guiding Sheath (Catalog Numbers: D-1385-01-S and D-1385-02-S) Lot Numbers 00002137 and 50000224 and segregate the product. For assistance in identifying impacted product, please reference ATTACHMENT 1: PRODUCT IDENTIFICATION TOOL. 4. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. 5. If you have inventory affected by this action: 5.1. Return inventory to Sedgwick using the enclosed return label. 5.2. Complete and sign the Business Response Form 5.3. Scan the signed completed form and email it to: BWI7774@sedgwick.com or Fax it to 888-877-7241. Subject: Attention: BWI Field Action Event #7774 6. If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this to the relevant personnel. 7. Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026