Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2702-2017 — 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

U.S. FDA — Device Enforcement · United States · 2017-06-09 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2702-2017
Date of alert: 2017-06-09
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Penumbra Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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