Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alamed
FDA device recall Z-1906-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- Penumbra Inc.
- Reason for recall
- The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
- Action taken
- Penumbra sent an Urgent Voluntary Field Removal Notice dated March 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately inspect all stock of Penumbra Coil 400 and identify product from the Lots. Remove product from these Lots from inventory and place it in quarantine for return to Penumbra Inc. (Do not use product from these Lots). Complete and return the attached product identification/ return form with in 5 business days via fax to +1 510-217-6414. Penumbra employees will contact customer directly to arrange return and replacement of product. For questions call Regulatory Affairs at 510-748-3224 or e-mail RAQA@prenumbrainc.com.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HCG
- Quantity affected
- 2082
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.
- Date initiated
- 2011-03-04
- Date posted
- 2011-04-12
- Date terminated
- 2011-06-06
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PENUMBRA EMBOLIZATION COIL SYSTEM (K103305) | Penumbra, Inc. | 2011-01-26 |