Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Due to manufacturing issues, reperfusion catheters may fractures

On June 2, 2026, Penumbra issued a Urgent Medical Device Recall Notification to affecte consignees via FedEx. Penumbra asked consignees to take the following actions: 1. Review inventory and remove affected units from inventory and place in quarantine for return. 2.Complete and return the response form to notifications@penumbrainc.com. Your Penumbra representative will work with you directly to arrange return and credit of affected devices. If you do not have any affected product, please still complete the response form and return. 3. Share recall notification with all users of the product within your facility.

• FDA enforcement recordOfficial FDA database entry for Z-2770-2026
• FDA 510(k) clearance · K211411The device's official FDA premarket clearance record
• FDA device classification · NRYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Penumbra, Inc.Search 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.