Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra Syste…

Due to manufacturing issues reperfusion catheters may fracture.

On 07/24/2026, an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" was sent via email and FedEx Priority Overnight to customers informing them that Penumbra has identified an issue (frature) in the lot H00007856 of the Penumbra System RED 62 Reperfusion Catheter (RED 62). Actions Customers need to take: " Share this Recall Notification with all users of the product within your facility " Review inventory for the specified lot listed above " If you do have inventory of the specified lot listed above, remove affected units from inventory and place in quarantine for return to Penumbra, Inc. Complete and return the Product Identification/Return Notification to notifications@penumbrainc.com within 3 business days. Your Penumbra Sales Representative will work with you directly to arrange return and credit. " If you do not have inventory of the specified lot listed above, complete and return the Product Identification/Return Notification form to notifications@penumbrainc.com within 3 business days. No further action is required. For questions - contact Penumbra Sales Representative or email at notifications@penumbrainc.com.

• FDA enforcement recordOfficial FDA database entry for Z-3331-2026
• FDA 510(k) clearance · K203440The device's official FDA premarket clearance record
• FDA 510(k) clearance · K250690The 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.