Z-2702-2017Class I

Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute...

Name: Z-2702-2017 Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute...
Creator: Penumbra Inc.
Published: 2017-06-09
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2017-06-09 / Terminated

FDA source

Penumbra Inc. began a recall of Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large... on 2017-06-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2702-2017
Classification: Class I
Status: Terminated
Initiated: 2017-06-09
Posted: 2017-06-22
Terminated: 2019-05-09
Recalling firm: Penumbra Inc.
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.
Product code: NRY Catheter, Thrombus Retriever
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.
FDA root cause: Component change control
Action: Penumbra sent an Urgent Voluntary Field Removal Notice dated June 9, 2017. Customers were instructed to inspect current inventory and remove any affected units for return. Customers were also instructed to return the response form. 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. Penumbra personnel will contact customers directly to arrange return of affected units and replacement of returned product at no charge to them. Customers with question should call 1-510-748-3288.
Quantity in commerce: 155 units
Distribution: 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
Product codes and lots: Lots C00644, C00645, C00646, C00717

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2702-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2702-2017	Class I	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-20

Product code NRY

K162901Class IIPenumbra 3D Revascularization DevicePenumbra, Inc. / cleared 2017-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)