medical MODERATE Updated 2026-10-07

Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) P

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Recalled Product

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

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Hazard / Issue

Due to manufacturing issues reperfusion catheters may fracture.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI: 00815948024359 Lot Number: H00007856

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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