CS300 Intra-Aortic Balloon Pump
FDA device recall Z-1812-2010 · posted 2010-06-21 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 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, Singapo
- Date initiated
- 2010-05-10
- Date posted
- 2010-06-21
- Date terminated
- 2010-10-27
- Location
- Fairfield, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |