Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA Recall Z-2770-2026 · Posted 2026-07-21
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Reason for Recall
Due to manufacturing issues, reperfusion catheters may fractures
Firm Action
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 [email protected]. 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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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