CARTO VIZIGO 8 — Class II medical device recall Z-1677-2022
Ongoing recall by Biosense Webster, Inc., reported 2022-09-14, distributed nationwide. Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained wa
| Recall number | Z-1677-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-09-02 |
| Reported by FDA | 2022-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 98 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10846835016253 |
| Lot numbers | 00002001 |
| Model numbers | D138501 |
Product
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1677-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.