FDA Drops Pediatric VADs From Shortage List, Adds Breast Biopsy Needles and Angiographic Syringes

The US Food and Drug Administration has taken pediatric ventricular assist devices off its Medical Device Shortages List and added stereotactic breast biopsy needles and angiographic control syringes with rotating adapters, according to the agency's list as archived on March 18. The update appears to be the first change to the list since July 2025, Medical Design & Outsourcing reported on March 26.

The FDA's list dates both additions to March 13. It estimates that stereotactic breast biopsy needles (product code KNW) will be in shortage through the fourth quarter of 2026, and that angiographic control syringes with rotating adapters (product code DXT) will be short through the third quarter of 2026. For both, the listed reason for the interruption is a shortage or discontinuance of a component, part or accessory of the device.

Pediatric VADs come off the list

Pediatric ventricular assist bypass devices (product code DSQ) had been on the list since July 2025, when manufacturer Berlin Heart cited an unexpected increase in demand for its Excor Pediatric VADs, according to Medical Design & Outsourcing. The outlet said the Excor Pediatric is the only device approved to provide children with mechanical circulatory support as a bridge to heart transplantation.

With the two additions and the removal, the list now totals six product codes, the outlet reported.

Four shortages extended to mid-2026

The FDA also updated the estimated duration of four existing shortages to the second quarter of 2026: endoscopic vessel harvesting devices (product code GEI), bloodlines used in dialysis (FJK), and two types of oxygenators for extracorporeal circulation, one for long-term support greater than six hours (BYS) and one for cardiopulmonary bypass (DTZ). The agency has issued letters to health care providers for the vessel harvesting devices and the dialysis bloodlines, according to the list.

Separately, the FDA archived discontinuances reported between 2020 and 2024 on its companion Discontinuance List and added discontinuances reported since January 2025. Medical Design & Outsourcing reported that the agency added 42 product codes to the discontinuance list, including 42 AirLife respiratory products made by SunMed Group Holdings, such as respiratory tubing, noncontinuous ventilator components and breathing circuit filters.

How the list works

Section 506J of the Federal Food, Drug, and Cosmetic Act requires the FDA to maintain a publicly available, up-to-date list of devices it has determined to be in shortage, the agency says on the page. The FDA notes that a device type's presence on the list "does not necessarily indicate that patient care has been affected."

The list is managed by the Office of Supply Chain Resilience within the agency's Center for Devices and Radiological Health, which the FDA says is responsible for anticipating and preventing disruptions to the medical device supply chain. The FDA separately keeps the list of devices that manufacturers have told it are permanently discontinued.