VIZIGO recallZ-1677-2022 · Biosense Webster, Inc. · initiated Jun 29, 2022
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
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.
FDA root cause category: Material/Component Contamination
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-1677-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 29, 2022
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 98
- Product code
- DYB
- FDA submissions
- K170997
- 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.
Product description
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Code information (models, lots, serial numbers)
UDI-DI: 10846835016253, Lot Number: 00002001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
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.
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- CARTO VIZIGO D138504Biosense Webster Inc · Introducer, catheter2 deaths288 reports
- CARTO VIZIGO D138505Biosense Webster Inc · Introducer, catheter61 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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