Penumbra 3D Revascularization Device Recall: Delivery Wire Breakage Risk
Penumbra recalls four lots of 3D Revascularization Devices due to potential delivery wire breakage causing serious injury or death during acute stroke treatment.
Stop using this now
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.
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What happened, in plain English
Penumbra is recalling four specific lots of their 3D Revascularization Device because a raw material issue might cause the delivery wire to break. This could lead to serious injury or death during acute stroke treatment. Read more at govinfonow.com/recall/73891-penumbra-3d-revascularization-device-recall-delivery-wire-breakage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73891-penumbra-3d-revascularization-device-recall-delivery-wire-breakage-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2702-2017
Cite this page
“Penumbra 3D Revascularization Device Recall: Delivery Wire Breakage Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73891-penumbra-3d-revascularization-device-recall-delivery-wire-breakage-risk. Based on FDA recall #Z-2702-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2702-2017%22&limit=1).
Why it’s dangerous
The delivery wire in these lots could break during use, potentially causing serious injury or death. This happens because the raw material component has a defect that weakens the wire under stress during critical stroke procedures.
Who’s affected
Patients using the recalled device for acute ischemic stroke treatment within 8 hours of symptom onset. Those with the specific lot numbers C00644, C00645, C00646, or C00717 are most at risk.
How to tell if you have this one
Check the lot number on the device packaging. The recalled lots are C00644, C00645, C00646, and C00717. This device is used for acute ischemic stroke treatment within 8 hours of symptoms.
- Brand
Penumbra- Category
Medical device
What to do — step by step
Stop Using Device Now
Immediately stop using the device if it has one of the recalled lot numbers: C00644, C00645, C00646, or C00717.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Indiana, Massachusetts, Michigan, Minnesota, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2702-2017 (June 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2702-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.