The recalls involve different medical technologies used in patient care. The Astral 100 and Astral 150 ventilators provide mechanical ventilation support, while the 14Fr Low Profile Introducer Kit is used to help access the vascular system during procedures involving Impella CP devices. The FDA said the affected products require specific responses from healthcare providers, patients, and facilities.
ResMed Ventilator Recall Linked to Possible Supercapacitor Failure
The FDA classified the ResMed Astral ventilator correction as a Class I recall after the company identified a potential issue with a component called a supercapacitor. According to the FDA, the component may leak over time and damage circuitry on the printed circuit board assembly (PCBA), which can cause the ventilator to enter a fail-safe state.
The affected devices include certain Astral 100 and Astral 150 ventilators built before October 2024, along with specific PCBA spare parts. If the issue occurs while therapy is being delivered, the ventilator may stop providing support, activate a high-priority alarm, and display system fault messages. According to the FDA, the device may no longer be able to deliver therapy until corrective action is taken.
The FDA advised patients not to stop using affected ventilators unless instructed by their clinician. Healthcare providers should identify whether installed main boards are affected and make sure alternative ventilation equipment is available when needed. The agency noted that replacement PCBA availability is limited, leading ResMed to use a phased approach focused first on inspection and risk management for patients with the highest clinical risk. According to the FDA, ResMed reported five serious injuries and no deaths associated with this issue as of June 23, 2026.
Abiomed Introducer Kit Recall Involves Thrombus Formation Risk
The FDA also classified a recall involving Abiomed’s 14Fr Low Profile Introducer Kits as Class I. The company recommended removing affected products from use or sale after identifying a higher-than-expected number of complaints related to thrombus formation during prolonged use of the introducer.
The affected products include certain kits used with the Impella CP with SmartAssist system. According to the FDA, thrombus formation inside the sheath or around the valve may interfere with blood flow near the access site. If a thrombus becomes dislodged during support, manipulation, or removal, patients may require medical assessment and intervention.
Healthcare facilities were instructed to review inventory, quarantine affected products, and return them. The recall applies to specific product codes, including 1000434, 1000435, and 1000413, while the FDA stated that other commercially available generations of Impella CP are not involved.
According to the FDA, Abiomed reported three serious injuries and no deaths connected to this issue as of May 15, 2026. The FDA’s Class I classification indicates that continued use of affected devices without the recommended actions may present a risk of serious harm. The agency continues to provide updates through its medical device safety communications as companies carry out corrective measures.
