FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
- Recall number
- Z-1285-2021
- Recalling firm
- Biosense Webster, Inc.
- Product
- Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
- Status
- Completed
- Initiated
- 2021-02-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Root cause
- 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.
- Quantity
- 71,473 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- ["K170997"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2029046
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28