| Date Initiated by Firm | January 08, 2007 |
|---|
| Date Posted | March 07, 2007 |
|---|
| Recall Status1 |
Terminated 3 on February 07, 2008 |
| Recall Number | Z-0574-2007 |
|---|
| Recall Event ID |
37170 |
| Product Classification |
Circulatory Support System - Product Code DSQ
|
| Product | AB5000 Console Circulatory Support System
Catalog Number: 0015-0000 |
|---|
| Code Information |
Serial Numbers: 5261- 5317 |
Recalling Firm/
Manufacturer |
Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
|
| For Additional Information Contact | William Bolt
978-777-5410 |
|---|
Manufacturer Reason
for Recall | Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components. |
|---|
| Quantity in Commerce | 55 units |
|---|
| Distribution | Worldwide, including USA, Japan, Germany, Australia, and Mexico. |
|---|
| 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.
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