Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16489 |
| Brand Name: | Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP) |
| Model: | Models: System 98/98XT, CS100, CS100i, CS300 |
| Affected: | Manufactured between 1-Jan-2003 and 30-Jun-2011 |
| Software version: | |
| Recalling Organisation: | Maquet Australia Pty Ltd (NZ) 12G Andromeda Cres East Tamaki Auckland 2013 |
| Contact Information: | 021 874 882 |
| Manufacturer: | Datascope Corporation |
| Issue: | The manufacturer has identified a potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/4/2014 |
