Recall Z-1677-2022— Biosense Webster, Inc.
Class II · Ongoing
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2022-06-29. It names one FDA 510(k) clearance: K170997. 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..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-29
- Firm location
- Irwindale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.