Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic s
FDA device recall Z-2702-2017 · posted 2017-06-22 · Terminated
Recall details
- Recalling firm
- Penumbra Inc.
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- NRY
- Quantity affected
- 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
- Date initiated
- 2017-06-09
- Date posted
- 2017-06-22
- Date terminated
- 2019-05-09
- Location
- Penumbra Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Penumbra 3D Revascularization Device (K162901) | Penumbra, Inc. | 2017-04-20 |