| Date Initiated by Firm | January 30, 2015 |
|---|
| Date Posted | February 23, 2015 |
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| Recall Status1 |
Terminated 3 on September 29, 2017 |
| Recall Number | Z-1140-2015 |
|---|
| Recall Event ID |
70510 |
| 510(K)Number | K112372 |
|---|
| Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
| Product | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) |
|---|
| Code Information |
0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected. |
Recalling Firm/
Manufacturer |
Maquet Datascope Corp - Cardiac Assist Division
1300 MacArthur Blvd.
Mahwah NJ 07430-2052
|
| For Additional Information Contact |
800-777-4222 |
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Manufacturer Reason
for Recall | Power supply malfunction complaints related to suboptimal thermal management. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Maquet Inc. sent a recall letter/return response form dated 1/30/2015. |
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| Quantity in Commerce | 1,300 units |
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| Distribution | US Nationwide distribution |
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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 = DSP
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