Penumbra 3D Revascularization Device It is indicated recall
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to…
Why was Penumbra 3D Revascularization Device It is indicated 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots C00644, C00645, C00646, C00717
- Product
- Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to…
- Recalling firm
- Penumbra Inc.
- Quantity
- 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
- Recall date
- July 26, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)