Penumbra 3D Revascularization Device recallZ-2702-2017 · Penumbra Inc. · initiated Jun 9, 2017
Class I Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Component change control
What the company is doing
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.
Recall details
- Recall number
- Z-2702-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jun 9, 2017
- Posted by the FDA
- Jun 22, 2017
- Recalling firm
- Penumbra Inc.
- Quantity
- 155 units
- Product code
- NRY
- FDA submissions
- K162901
- 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 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.
Code information (models, lots, serial numbers)
Lots C00644, C00645, C00646, C00717
Other devices under the same FDA submission
3 devices cleared under K162901 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Penumbra System PSR3D-APenumbra, Inc. · Catheter, Thrombus Retriever6 deaths55 reports
- Penumbra System PSR3DPenumbra, Inc. · Catheter, Thrombus Retriever26 reports
- Penumbra System ACE683DVELSYS-APenumbra, Inc. · Catheter, Thrombus Retriever1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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