Z-2702-2017 Class I Terminated
FDA device recall Z-2702-2017 was initiated by Penumbra Inc. on June 9, 2017 and is designated Class I. 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 s… The recall status is terminated (terminated May 9, 2019). Affected quantity: 155 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2017
- Initiation Date
- June 9, 2017
- Termination Date
- May 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155 units
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.
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
Code Information
Lots C00644, C00645, C00646, C00717