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U.S. Department of Health and Human Services

Class 2 Device Recall Penumbra RED 68 Reperfusion Catheter

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 Class 2 Device Recall Penumbra RED 68 Reperfusion Cathetersee related information
Date Initiated by FirmJune 03, 2026
Date PostedJuly 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2770-2026
Recall Event ID 99148
510(K)NumberK211411 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductPenumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Code Information UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
FEI Number 3013758550
Recalling Firm/
Manufacturer		 Penumbra, Inc.
6262 Patterson Pass Rd Ste A
Livermore CA 94550-9576
For Additional Information ContactShruthi Narayan
+1-765-7023892
Manufacturer Reason
for Recall		Due to manufacturing issues, reperfusion catheters may fractures
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NRY
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