Recall Z-1812-2010 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
CS300 Intra-Aortic Balloon Pump
| Date | Jun 21, 2010 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen. |
| Root cause | Other |
| Action | Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314. |
| Quantity | 161 total units |
| Distribution | Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM Datascope Corp., Jan 5, 2007 |