The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.
The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.
AED shortage update
The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.
The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared accessories such as batteries, pad electrodes and adapters. The FDA also cited the continued global shortage of semiconductor chips.
In January 2023, Stryker stopped manufacturing several models of its Physio-Control LIFEPAK 20e defibrillator/monitors. The FDA added those wearable AEDs to its discontinued list in June, but said alternatives were available for customers.
Medical devices removed from shortage list
The FDA removed four product codes from its medical device shortage list in December:
- Chest drains and suction canisters (product code KDQ)
- Chest drains with autotransfusion indications (product code CAC)
- Tracheostomy tube and tube cuff (product code JOH)
- Tracheostomy tube with and without connector (product code BTO)
The chest drains had been on the medical device shortage list since July 2022 due to increased demand.
The tracheostomy tubes had been on the list since October 2022 due to a shortage or discontinuance of a component, part or accessory of the device. That month, the FDA reported that manufacturers had difficulty obtaining raw materials, specifically citing flexible silicone used by ICU Medical to make its Bivona tracheostomy tube, commonly used in pediatric patients.
Due to a variety of factors — including increased demand, shipping delays and continued shortages of semiconductors and other components — the medical device shortages list still contains seven products across three categories:
- Cardiovascular: circulatory support, structural and vascular devices
- Cardiac diagnostic and monitoring products
- Dialysis-related products
As of the May 2023 expiration of the COVID-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.
Devices added to discontinuance list
Finally, the FDA added two products to its list of discontinued medical devices, including the Karl Storz Photodynamic Diagnostic D-Light C Flexible System.
But the more notable discontinuation is the HeartMate II LVAS, which the agency said Abbott will stop manufacturing as of Dec. 31, 2026. That discontinuation appears to apply to the entire HeartMate II line, including implants, controllers, display modules, accessories and products for demonstrations and training.
HeartMate developer Thoratec won PMA for the first-generation device in 1994 and the second-generation HeartMate II in 2008. St. Jude Medical purchased Thoratec for $3.3 billion in 2015; Abbott, in turn, purchased St. Jude for $25 billion in 2017.
Later that year, Abbott won PMA for the latest-generation HeartMate 3 as a bridge-to-transplantation for advanced-stage heart failure patients waiting for a transplant. A 2018 PMA expanded the device’s approved use to a life-long implant for advanced heart failure patients who are not eligible for a transplant.