Berlin Heart’s Excor Pediatric is the only FDA-approved ventricular assist device for infants and children awaiting heart transplants. [Photo courtesy of Berlin Heart]
The March 2026 update appears to be the first change to the agency’s device shortage list since July 2025.
The FDA also added 42 product codes to its medical device discontinuance list.
Pediatric VADs (product code DSQ) had been on the list since July 2025, with manufacturer Berlin Heart citing an unexpected increase in demand for its Excor Pediatric VADs, the only such device approved to provide children with mechanical circulatory support as a bridge to cardiac transplantation.
MassDevice: Cardio Device Companies Special Report
With the addition of stereotactic breast biopsy needles (product code KNW) and angiographic control syringes with rotating adapters (product code DXT), the medical device shortage list now totals six product codes.
Stereotactic breast biopsy needles are estimated to remain in short supply through the end of 2026. The shortage of angiographic control syringes with rotating adapters is estimated to extend through the third quarter 2026.
Devices with continued shortages include endoscopic vessel harvesting devices (product code GEI), bloodlines used in dialysis (product code FJK), Oxygenator devices intended for extracorporeal circulation used in long term support greater than six hours (product code BYS) and oxygenator devices intended for extracorporeal circulation in cardiopulmonary bypass (product code DTZ).
The FDA estimates these devices will remain in short supply through the first half of 2026.
Among the FDA’s latest additions to its list of permanently discontinued devices are 42 AirLife respiratory products made by SunMed Group Holdings, including respiratory tubing, noncontinuous ventilator components and breathing circuit filters.
