Recall Z-2702-2017— Penumbra Inc.

Name: FDA recall Z-2702-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-09

Class I · Terminated

Class I FDA medical device recall by Penumbra Inc., initiated 2017-06-09, terminated 2019-05-09. It names one FDA 510(k) clearance: K162901. 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..

Recalling firm: Penumbra Inc.
Classification: Class I
Status: Terminated
Initiated: 2017-06-09
Terminated: 2019-05-09
Firm location: Alameda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162901 — Penumbra 3D Revascularization DevicePenumbra, Inc.·cleared 2017-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.