FDA Issues Class I Recalls for Resmed Astral Ventilators and Abiomed Introducer Kits

The U.S. Food and Drug Administration identified Class I recalls — its most serious category — for certain Astral ventilators made by Resmed and for 14Fr Low Profile Introducer Kits made by Abiomed, according to the American Hospital Association, which reported the action on August 3, 2026.

The AHA reported that the Resmed recall concerns a supercapacitor that may leak over time. The Abiomed recall concerns thrombus formation following prolonged use of the introducer.

Class I is the FDA’s highest recall classification, used for situations in which there is a reasonable probability that use of the product will cause serious injury or death.

What is not yet established from this report: the number of devices affected, whether any injuries have been reported, and the corrective steps each manufacturer has directed for devices already in use. Patients and clinicians should consult the FDA’s medical device recall database and the manufacturers’ notices for device-specific instructions.

Story Details

Sources

• American Hospital Association — FDA announces highest recall for certain ventilators, introducer kits (Aug 3, 2026)
• FDA — Medical Device Recalls and Early Alerts

Every claim above is attributed to the sources listed.
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