Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)
Summary
The FDA issued a Class II for Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbr by Penumbra Inc.. Reason: Due to manufacturing issues reperfusion catheters may fracture..
Details
Source
Device Recall
External ID
Z-3331-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
Brand 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
Lot/Code Info: Lot Code: UDI: 00815948024359 Lot Number: H00007856
Quantity Affected: 43
Reason for Recall
Due to manufacturing issues reperfusion catheters may fracture.
Distribution
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-24
Company
Alameda, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Penumbra Inc. has 19 FDA actions in our database, including 2 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Penumbra Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Penumbra Inc. have FDA actions?
Penumbra Inc. has 19 FDA actions in our database, including 2 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3331-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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