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VIZIGO recallZ-1320-2023 · Biosense Webster, Inc. · initiated Feb 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected] 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.

Recall details

Recall number
Z-1320-2023
Status
Open, Classified
Initiated by the company
Feb 21, 2023
Posted by the FDA
Apr 1, 2023
Recalling firm
Biosense Webster, Inc.
Quantity
316 units
Product code
DYB
FDA submissions
K170997
Distribution
Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.

Product description

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

Code information (models, lots, serial numbers)

Lot # 50000224; UDI (GTIN) : 10846835016277

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K170997 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91797).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page