Penumbra Inc.: Medical Device Recall in 2017 - (Recall #: Z-2702-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: June 9, 2017

Date Posted: July 26, 2017

Recall Number: Z-2702-2017

Event ID: 77571

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.

Status: Terminated

Product Quantity: 155 units

Code Information:

Lots C00644, C00645, C00646, C00717

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated