CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It p
FDA device recall Z-0662-2013 · posted 2013-01-09 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
- Action taken
- Maquet Cardiovascular sent an Urgent Product Recall Letter dated March 27, 2012, and Urgent Product Recall Acknowledgement to all affected customers . The letter identified the product, the problem, and the action to be taken by the customer. Datascope Corp determined that the best course of action was to replace the affected product. Customers were instructed that they would be contacted by a service representative to make arrangements for the removal and replacement of their affected product. Customers with questions were instructed to contact the US Call Center at 1-800-777-4222. For questions regarding this recall call 973-709-7498.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 29 units (total)
- Distribution
- Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden,
- Date initiated
- 2012-03-27
- Date posted
- 2013-01-09
- Date terminated
- 2015-09-30
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |