Penumbra 3D Revascularization Device Recalled Due to Delivery Wire Breakage Risk
Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the defect could potentially lead to serious patient injury or death, which meets the criteria for a Critical severity score (5) under the rubric.
Plain-English summary
Penumbra Inc. is recalling 155 units of the Penumbra 3D Revascularization Device. The device is indicated for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset. The recall affects lots C00644, C00645, C00646, and C00717.
The recall was initiated because Penumbra 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.
The affected units were distributed nationwide to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WV. Healthcare providers and facilities should stop using the affected devices and contact Penumbra Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- Penumbra Inc.
- Category
- Medical Device — Neurovascular
- Affected units
- 155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots C00644
- C00645
- C00646
- C00717
Distribution
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