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VIZIGO recallZ-1290-2024 · Biosense Webster, Inc. · initiated Feb 16, 2024

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

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

FDA root cause category: Under Investigation by firm

What the company is doing

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 Instructions for Use, on Page 7, instructs users to inspect all components before use, and prior to inserting the device into the patient, pre-assemble the sheath, dilator, and stylet on the table. While setting up for a procedure, if the dilator is protruding out the tip of the sheath more than 4 inches (10 cm), do not use the sheath. Destroy the device following their standard process. Please complete the Attestation of destruction form (Attachment 2) to receive a replacement and email it to: Email: [email protected] Subject: Attention: BWI Field Action Coordinator- Attestation product destruction. For questions or further assistance, contact Biosense Webster at [email protected]

Recall details

Recall number
Z-1290-2024
Status
Open, Classified
Initiated by the company
Feb 16, 2024
Posted by the FDA
Mar 13, 2024
Recalling firm
Biosense Webster, Inc.
Quantity
853 units
Product code
DYB
FDA submissions
K170997
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.

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.

Code information (models, lots, serial numbers)

Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282

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.

Sources and updates

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