FDA Device recall Z-2702-2017
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to…
- FDA Device
- Class I
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class I recall of Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to… by Penumbra, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2702-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-06-09 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Penumbra |
| Distribution | US |
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
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.
Identifiers
| code_info | Lots C00644, C00645, C00646, C00717 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2702-2017%22
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