| TGA Action ID |
RC-2025-RN-00934-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cardiosave IABP
Cardiosave Hybrid
Product Codes: 0998-00-0800-31 - 0998-UC-0800-31, 0998-00-0800-53 - 0998-UC-0800-53
Cardiosave Rescue
Product Code: 0998-00-0800-83
All lot numbers manufactured since Dec 01, 2011 |
| ARTG Number |
118266 |
| Unique Device Identifier (UDI) |
10607567109053, 10607567108391, 10607567108407 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The Cardiosave IABP Instructions for Use (IFU) are being updated to address four identified risks:
Problem 1: the expected battery life of the NVRAM internal lithium battery is shorter than the expected service life of the Cardiosave. There is no guidance in the preventative maintenance schedule in the IFU to change the NVRAM internal battery. The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Problem 2: the medical device transportation standards referenced in the IFU were not the ones cited in verification study reports. The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Problem 3: Helium O-Ring Preventive Maintenance - This problem was previously communicated to customers in a letter dated February 22nd 2023 and then an updated letter dated 22 March, 2024 (RC-2023-RN-00142-1). The IFU Addendum contains an updated Schedule B Preventive Maintenance Schedule which calls for the Quick Disconnect Fitting O-Ring to be replaced and to lubricate the console release latch every 12 months or 2500 hours.
Problem 4: The previous product recall regarding impacted batteries has been completed (RC-2021-RN-02024-1), however changes are being made to the IFU regarding battery run time specification. The IFU addendum updates details the Battery Run Time is to be 80 Minutes Typical-new battery, 120 BPM, 22 +/- 5 degrees C min at 120 BPM |
| Instructions for Customers/Users |
Datascope created an IFU Addendum with clarification to the Battery Runtime and Vibration and Shock Table IFU information as well as updates to the Preventive Maintenance Schedule B for both NVRAM and the Helium O-Ring on the Quick-Disconnect Fitting.
The IFU addendum is available at: https://www.getinge.com/int/products-and-solutions/cardiovascular-procedures/iabp-counterpulsation/iabp-product-information/
If users require a physical copy they may request one from their local Datascope/Getinge representative. |
| Action Commencement Date |
4/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 - Getinge |