CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
System (RED 62 Reperfusion Catheter) recalled by Penumbra
Penumbra is recalling System (RED 62 Reperfusion Catheter), distributed nationwide in the US. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3331-2026
- FDA event ID
- 99591
- Recalling firm
- Penumbra, Alameda, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 24 Jul 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +67 days |
| 7 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing issues reperfusion catheters may fracture.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Nationwide AlabamaCaliforniaColoradoFloridaLouisianaNorth CarolinaNew YorkTexasUtahWisconsin
Questions about this recall
Why was it recalled?
Due to manufacturing issues reperfusion catheters may fracture.
Which lots are affected?
Lot Code: UDI: 00815948024359 Lot Number: H00007856
Where was it sold?
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Penumbra
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|---|---|---|---|---|---|
| Device | CLASS II | System RED 68 Reperfusion Catheter recalled by Penumbra | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX recalled | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 Reperfusion Catheter recalled by Penumbra | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled | Penumbra | Other | Nationwide |
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