medical MODERATE Updated 2026-07-29

Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

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Recalled Product

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

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Hazard / Issue

Due to manufacturing issues, reperfusion catheters may fractures

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038

✅ 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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View official government recall

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