Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit w/Copilot

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902

• FDA enforcement recordOfficial FDA database entry for Z-0732-2025
• FDA 510(k) clearance · K961471The device's official FDA premarket clearance record
• FDA device classification · MAVOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abbott Vascular IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.