| Date Initiated by Firm | July 05, 2010 |
|---|
| Date Posted | September 07, 2010 |
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| Recall Status1 |
Terminated 3 on September 10, 2010 |
| Recall Number | Z-2382-2010 |
|---|
| Recall Event ID |
56315 |
| 510(K)Number | K083111 |
|---|
| Product Classification |
pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
|
| Product | Impella 5.0 Circulatory Support System
Catalog number: 004840
The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours |
|---|
| Code Information |
Serial numbers: 45921,45922,45923,45924 |
Recalling Firm/
Manufacturer |
Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923
|
| For Additional Information Contact | SAME
978-777-5410 Ext. 225 |
|---|
Manufacturer Reason
for Recall | Pump may separate at the motor housing while device is explanted |
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FDA Determined
Cause 2 | Process control |
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| Action | ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used.
If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com. |
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| Quantity in Commerce | 10 units |
|---|
| Distribution | International only: Canada and France |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KFM
|
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