December 5, 2022 —  The U.S. Food and Drug Administration (FDA) is alerting well being care amenities and suppliers of a scarcity of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) units, together with restricted provides of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP components. 

Recommendations 

The FDA recommends that well being care amenities and suppliers who use Getinge Maquet/Datascope IAB catheters or IABP units: 

• Review the scarcity notification letterExternal Link Disclaimer from Getinge, which incorporates short-term upkeep updates for Cardiosave IABP Safety Disk and Lithium-Ion Battery. 
• Inform Getinge if in case you have any underutilized Maquet/Datascope IAB catheters or IABPs and are prepared to share them with hospitals in want. You can contact your Getinge Sales Representative. 
• Report any points with Getinge Maquet/Datascope IAB catheters or IABP units to the FDA. For particulars on reporting, see Reporting Problems to the FDA. 
•  

Background 

On November 29, 2022, Getinge posted a notification letterExternal Link Disclaimer on its web site informing clients of a scarcity of Maquet/Datascope IAB catheters, new Cardiosave IABP units, and Cardiosave IABP components, in addition to offering short-term steerage for the upkeep of the Cardiosave Safety Disk and Lithium-Ion Battery. 

FDA Actions 

The FDA is working with Getinge to establish potential methods to assist assist availability of those crucial units. The scarcity is estimated to proceed into the 12 months 2023. 

On December 2, 2022, the FDA added IABP units (product code DSP) to the medical device shortage list. The system scarcity listing displays the forms of units the FDA decided to be in scarcity. The FDA will proceed to replace the listing as wanted. The FDA additionally opinions every notification under section 506J of the Federal Food, Drug, and Cosmetic Act obtained and makes use of this data, together with any further particulars in regards to the provide and demand of a tool, to find out whether or not a tool is in scarcity. 

The FDA continues to observe the present scenario and can preserve well being care amenities, suppliers and the general public knowledgeable if vital new data turns into obtainable. 

Reporting Problems to the FDA 

If you’re experiencing provide points, contact the FDA about a medical device supply chain issue. Reporting provide points informs the FDA of the way it could possibly assist tackle system provide availability. 

The FDA encourages well being care suppliers to report any hostile occasions or suspected hostile occasions skilled with Getinge Maquet/Datascope IAB catheters or IABP units. 

Voluntary studies could be submitted by way of MedWatch, the FDA Safety Information and Adverse Event Reporting program. 

Device producers and person amenities should adjust to the relevant Medical Device Reporting (MDR) regulations. 

Health care personnel employed by amenities which are topic to the FDA’s user facility reporting requirements ought to comply with the reporting procedures established by their amenities. 

Prompt reporting of hostile occasions may help the FDA establish and higher perceive the dangers related to medical units. 

Contact Information 

If you might have questions on this letter, contact the Division of Industry and Consumer Education (DICE).