# FDA recall Z-2702-2017

> **Penumbra Inc.** · Class I · device recall initiated 2017-06-09.

## 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 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

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

## Key facts

- **Recall number:** Z-2702-2017
- **Recalling firm:** Penumbra Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-09
- **Report date:** 2017-07-26
- **Termination date:** 2019-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2702-2017

## Citation

> AI Analytics. FDA recall Z-2702-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2702-2017. Source: US FDA. Licensed CC0.

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