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U.S. Department of Health and Human Services

Class 2 Device Recall CARTO VIZIGO 8.5F BiDirectional Guiding Sheath

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  Class 2 Device Recall CARTO VIZIGO 8.5F BiDirectional Guiding Sheath see related information
Date Initiated by Firm February 26, 2021
Create Date March 22, 2021
Recall Status1 Completed
Recall Number Z-1287-2021
Recall Event ID 87440
510(K)Number K170997  
Product Classification Introducer, catheter - Product Code DYB
Product Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Code Information All Lots 
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
Manufacturer Reason
for Recall		 There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
FDA Determined
Cause 2		 Device Design
Action On 2/26/21, Biosense Webster sent an "Urgent: Medical Device Correction" notification to all affected consignees via UPS. In addition, to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Precaution on inserting a dilator into VIZIGO Bi-Directional Guiding Sheath: " Use best practices for inserting or retracting any device at the hemostatic valve. " Do Not remove dilator or catheter rapidly. Damage to hemostatic valve may occur. " Aspirate slowly, only from the sideport. " Slowly remove or insert the dilator or other devices. " Once the sheath is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is achieved prior to flushing or infusion. " Prior to inserting the device into the patient, pre-assemble sheath, dilator and stylet on the table. Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly. " Before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate. After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli. 2. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 3. Please complete, sign, and return the Business Reply Form.
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Biosense Webster, Inc.
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