FDA Device recall Z-1677-2022
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501 by Biosense Webster, citing 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 produc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1677-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-29 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biosense Webster |
| Distribution | US |
Product
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
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.
Identifiers
| code_info | UDI-DI: 10846835016253, Lot Number: 00002001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1677-2022%22
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