FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
- Recall number
- Z-1677-2022
- Recalling firm
- Biosense Webster, Inc.
- Product
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
- Status
- Open, Classified
- Initiated
- 2022-06-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
- Root cause
- Material/Component Contamination
- Action
- On 6/29/22, re call notices started being emailed and mailed to customers who were asked to do the following: 1) The notice should be forwarded to anyone in the facility that needs to be aware. 2) Identify affected devices, unbox devices, and destroy the devices. 3) Complete and return the Business Reply Form and send back the label on empty boxes to receive credit. 4) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 5) Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed. If you have additional questions about this letter, please email the recalling firm at OneMD-Field-Actions@its.jnj.com
- Quantity
- 98
- Distribution
- US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.
- Lot, serial or model codes
- UDI-DI: 10846835016253, Lot Number: 00002001
- 510(k) numbers
- ["K170997"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3003113629
- 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