Class I — Penumbra Inc.
| Recalling firm | PENUMBRA, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. |
| Product | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. |
| Quantity | 155 units |
| Distribution | Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV |
| Initiated | 2017-06-09 |
| Classified | 2017-07-20 |
| Terminated | 2019-05-09 |
| Recall number | Z-2702-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Penumbra Inc. (Z-2702-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77571/
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