December 22, 2021
The U.S. Food and Drug Administration (FDA) is providing updated information about our ongoing evaluation and monitoring of device failures associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including the Cardiosave (Hybrid and Rescue), CS300, and CS100/CS100i.
The FDA recently became aware that Maquet/Datascope Cardiosave Hybrid and Rescue IABP devices may not recognize AC/wall power when devices are plugged in, which may lead to devices unexpectedly shutting down.
The FDA previously communicated in November 2018 and November 2019 about reports of Maquet/Datascope IABP devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support. In 2019, the manufacturer initiated a voluntary recall to conduct training visits and review battery quick reference guides with users.
Since September 2021, the manufacturer has announced three voluntary recalls related to the potential for device failure with Cardiosave Hybrid and Rescue IABP devices.
- Cardiosave IABP devices may unexpectedly shut down during a very specific set of conditions: when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. The manufacturer is developing a software correction to address this issue. See the FDA Recall Database for more information.
- Certain Cardiosave Li-Ion Battery Packs may experience unexpected short battery runtime and should not be used. See the FDA Class I Recall Notice for more information.
- Fluid entering the Cardiosave IABP device may cause unexpected pump shutdown or the inability to initiate therapy. The manufacturer will install an ingress prevention upgrade kit to address this issue for Cardiosave IABP devices and will also provide redesigned display and rescue covers for Cardiosave Rescue IABP devices. See the FDA Class I Recall Notice for more information.
The FDA wants to ensure that health care providers and users of Maquet/Datascope Cardiosave IABP devices are aware of the potential for unexpected shutdown events and the manufacturer’s notices about the recent recalls. These devices are used to treat critically ill patients in health care facilities, including transport. An interruption in treatment can result in serious patient injury or death.
While the FDA remains concerned about device shutdown events associated with Maquet/Datascope IABP devices, the FDA recognizes that these systems may be the best option for circulatory support for some patients.
The FDA recommends that Maquet/Datascope Cardiosave IABP device users and health care providers:
- Be aware that device failures (while running on battery power or AC power) continue to be observed in patients treated with Maquet/Datascope Cardiosave IABP devices.
- Strongly consider having additional charged IABP devices available and ready in the event of device failure.
- Ensure Cardiosave IABP devices are not susceptible to shutting down during the removal of a battery.
- DO NOT eject a battery when:
- There is a singular battery in either battery charging bay and the unused battery bay is empty, and
- The battery is charging on AC power (indicated by a flashing LED on the battery pack).
- Check that a battery is inserted into each of the two battery bays.
- DO NOT eject a battery when:
- Examine your inventory to determine if you have any of the affected Cardiosave Li-Ion Battery Packs.
- Replace any affected battery with an unaffected battery and remove affected product from areas of use.
- Affected products are eligible for credit or replacement at no cost.
- Never place fluids on top of the unit. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists.
- Use the Plastic Weather Display and Rescue Cover any time the Cardiosave Rescue IABP is used outdoors, especially when there is the possibility of wet weather.
- Report to the FDA events of IABP devices shutting down while running on battery power or AC power, as well as any other battery issues or other device failures or patient injuries as a result of the device that occur. For details on reporting, see Reporting Problems to the FDA.
- When possible, return devices associated with, or suspected to be associated with, any adverse events or device malfunction or failure to the manufacturer for evaluation to help them and the FDA better understand the issue.
- Contact Getinge if you have any questions about the recent Cardiosave recalls or did not receive the manufacturer’s customer letters, at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. EST.
The FDA recommendations from the November 2019 letter to health care providers have not changed for Maquet/Datascope IABP device users and servicers.
The Maquet/Datascope lABP is a cardiac assist device placed in the descending aorta, just distal to the left subclavian artery. The device is an electromechanical system used to inflate and deflate intra-aortic balloons, which provides temporary support to the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Getinge no longer manufactures the CS300 and CS100/CS100i IABP devices; however, these devices may still be in use. The currently available Maquet/Datascope IABP devices are the Cardiosave Hybrid and Rescue.
Since 2017, the FDA has been evaluating medical device reports of Maquet/Datascope IABP devices shutting down. There may be multiple root causes for the device failures, and the FDA continues to work with Getinge to understand the root causes and possible risk mitigation measures. In 2019, the manufacturer initiated a voluntary recall due to the potential risk of battery failure in which Getinge contacted customers to schedule a training visit to review updated battery instructions, and instructions for use, care and maintenance. Additionally, the manufacturer provided a quick reference guide specific to each IABP device based on the Operating Instructions Manual(s).
At this time, the extent of the root causes or incidence rate of Maquet/Datascope IABP devices shutting down while running on battery power or AC power is not known. The FDA continues to evaluate information from the manufacturer to determine factors which may contribute to device failure events, as well as possible risk and mitigation measures.
The manufacturer is planning to implement software changes for Cardiosave IABP devices that are intended to address issues with batteries and device failures. The proposed software changes need to be submitted to the FDA for review and clearance. The manufacturer will install various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit for Cardiosave IABP devices. The manufacturer will also provide redesigned Display and Rescue Covers for Cardiosave Rescue IABP devices The FDA will work expeditiously to review any changes from the manufacturer that may affect patient safety and will continue to monitor actions being taken by the manufacturer to address IABP device failure.
The FDA continues to work with the manufacturer to examine and address the root causes of Maquet/Datascope Cardiosave IABP device failures while running on battery power or AC power and will keep the public informed if any significant new information or recommendations become available.
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Getinge Maquet/Datascope IABP devices.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).