| TGA Action ID |
RC-2026-RN-00481-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Intra-Aortic Balloon Pumps (IABP) CS100 and CS300
CS100 IABP
Product Code/Part Numbers: 0998-00-3013-55, 0998-UC-3013-55
CS300 IABP
Product Code/Part Numbers: 0998-00-3023-55, 0998-UC-3023-55 |
| ARTG Number |
118266 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
This Critical Product Alert is a follow-up to RC-2026-RN-00041-1, dated January 2026.
Datascope has become aware of instances where the device did not provide the expected runtime during some portable IABP uses in CS100/CS300 devices. Datascope recently completed additional testing on the CS100/CS300 batteries and identified the battery runtime and cycle specifications contained in the devices’ Instructions for Use (IFU) were incorrect and need to be updated. No other CS100/CS300 IABP performance deficiencies were identified.
As of December 2025, there have been over 200 complaints/reports including one (1) death and one (1) serious injury associated with batteries that did not meet the battery runtime of 135 minutes or the 100 full discharge cycles. Further investigation regarding battery performance remains ongoing. |
| Instructions for Customers/Users |
While the investigation remains ongoing, customers are to:
1. Where possible, use the device only while connected to AC power.
2. Make alternative arrangements for IABP support during transport.
3. If battery use is unavoidable, refer to the updated IFU specifications.
· Please forward this information to all current and potential CS300 and/or CS100 Intra-Aortic Balloon Pump users.
· Confirm Users are aware of IFU clarifications for batteries. Replace CS100/CS300 batteries (Part #: 0146-00-0039) every three years, and when a battery fails the Battery Runtime Test. No additional Preventative Maintenance or testing is required.
· Complete and sign the attached Customer Response Form.
Once investigation is complete, further updates will be provided. |
| Action Commencement Date |
24/07/2026 |
| Responsible Entity |
|
| Contact Information |
Quality.AUNZ@getinge.com - Getinge |