Class II U.S. Food and Drug Administration

Brand Name: Penumbra System Product Name: Penumbra System Model/ recall: Due to manufacturing issues reperfusion catheters may fracture

Recall published 18 days ago

Due to manufacturing issues reperfusion catheters may fracture.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to manufacturing issues reperfusion catheters may fracture.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3331-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Penumbra Inc.
Product type
Medical devices
Units affected
43
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: UDI: 00815948024359 Lot Number: H00007856
UPC codes
00815948024359

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00815948024359

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI
  • H00007856 — 43

Model or item number

On the rating label, the box or the instruction sheet.

  • THNDRRED62SKIT Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Penumbra Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Penumbra Inc. — 1 Penumbra, Alameda, CA, 94502-7610

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Penumbra Inc. medical devices recalled?

Due to manufacturing issues reperfusion catheters may fracture. Due to manufacturing issues reperfusion catheters may fracture.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00815948024359; lot code UDI, H00007856 — 43; model number THNDRRED62SKIT Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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