Update: August 31, 2023
Today, the FDA issued a Letter to Health to Care Providers to provide updated information about device failures for Getinge/Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) devices. See the Letter to Health Care Providers for more information on the latest recalls and recommendations to users.
December 2, 2022
The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.
The FDA recommends that health care facilities and providers who use Getinge Maquet/Datascope IAB catheters or IABP devices:
- Review the shortage notification letter from Getinge, which includes temporary maintenance updates for Cardiosave IABP Safety Disk and Lithium-Ion Battery.
- Inform Getinge if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need. You can contact your Getinge Sales Representative.
- Report any issues with Getinge Maquet/Datascope IAB catheters or IABP devices to the FDA. For details on reporting, see Reporting Problems to the FDA.
On November 29, 2022, Getinge posted a notification letter on its website informing customers of a shortage of Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts, as well as providing temporary guidance for the maintenance of the Cardiosave Safety Disk and Lithium-Ion Battery.
The FDA is working with Getinge to identify potential strategies to help support availability of these critical devices. The shortage is estimated to continue into the year 2023.
On December 2, 2022, the FDA added IABP devices (product code DSP) to the medical device shortage list. The device shortage list reflects the types of devices the FDA determined to be in shortage. The FDA will continue to update the list as needed. The FDA also reviews each notification under section 506J of the Federal Food, Drug, and Cosmetic Act received and uses this information, along with any additional details about the supply and demand of a device, to determine whether a device is in shortage.
The FDA continues to monitor the current situation and will keep health care facilities, providers and the public informed if significant new information becomes available.
If you are experiencing supply issues, contact the FDA about a medical device supply chain issue. Reporting supply issues informs the FDA of how it may be able to help address device supply availability.
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Getinge Maquet/Datascope IAB catheters or 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).