Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Penumbra System (RED 62 Reperfusion Catheter)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Penumbra System (RED 62 Reperfusion Catheter)see related information
Date Initiated by FirmJuly 24, 2026
Date PostedSeptember 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3331-2026
Recall Event ID 99591
510(K)NumberK203440 K250690 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductBrand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System
Code Information Lot Code: UDI: 00815948024359 Lot Number: H00007856
FEI Number 3005168196
Recalling Firm/
Manufacturer		 Penumbra Inc.
1 Penumbra
Alameda CA 94502-7610
For Additional Information ContactShruthi Narayan
+1-765-7023892
Manufacturer Reason
for Recall		Due to manufacturing issues reperfusion catheters may fracture.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce43
DistributionUS Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
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
-
-