Penumbra 3D Revascularization Device It is indicated for used in the… — Class I medical device recall Z-2702-2017
Terminated recall by Penumbra Inc., reported 2017-07-26, distributed nationwide. Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. T
| Recall number | Z-2702-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Penumbra Inc., Alameda, CA, United States |
| Recall initiated | 2017-06-09 |
| Classified | 2017-07-20 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2019-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 155 units |
| Reason classes | device malfunction |
| Lot numbers | C00644, C00645, C00646, C00717 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2702-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.