The FDA has placed pediatric ventricular assist bypass devices on its medical device shortage list.
The agency warned that reduced availability could alter the way clinicians manage children who need mechanical circulatory support.
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At the same time, the agency removed intra-aortic balloon and control systems (product code DSP) from the list after supplies stabilized. The devices were placed on the shortage list in December 2022. The FDA also pushed the expected shortage end dates for three other device categories – GEI, BYS and DTZ – to the fourth quarter of 2025.
The following devices remain on the shortage list:
- Some electrosurgical, cutting and coagulation devices and accessories (product code GEI).
- Bloodline tubing used in dialysis (product code FJK).
- Pediatric ventricular assist devices (product code DSQ).
- Oxygenator devices for extracorporeal circulation (product code BYS).
- Oxygenator devices for extracorporeal circulation in cardiopulmonary bypass (product code DTZ).
The shortage list, required under Section 506J of the Federal Food, Drug and Cosmetic Act, is meant to keep hospitals, physicians and purchasers informed about supply constraints. The presence of a device type on the list does not necessarily mean patient care has been affected, the agency said.
