The FDA has flagged four medical device recalls, corrections and early alerts affecting heart pump controllers, ventilators, automated compounding systems and thoracic stent grafts.
Here are four recalls to know:
1. Heart pump controllers (Abiomed): On May 21, the FDA issued an early alert after Abiomed recommended updated use instructions for all Automated Impella Controllers. A software error may cause the controller to restart when used with left ventricular Impella devices — during a restart, the pump stops for approximately 35 seconds, leaving the patient unsupported and at risk for regurgitation via the cannula. The pump automatically resumes at the previous setting after restarting. Abiomed is working on a software fix and product is not being removed from service. The FDA reported two serious injuries and one death.
2. Ventilators (React Health): On May 21, React Health recalled certain VOCSN V+Pro ventilators due to a manufacturing process deviation that may result in an undetected oxygen leak. Because of a production testing error, some devices may not have been evaluated under all intended high-pressure conditions, meaning a leak could reduce delivered oxygen levels below intended thresholds or increase fire risk in oxygen-enriched environments. Facilities are instructed to immediately stop use and transition patients to unaffected devices. The FDA reported no serious injuries or deaths.
3. Automated compounding systems (Omnicell): On May 21, the FDA confirmed a Class I recall of certain syringe labels used with Omnicell’s i.v.STATION automated compounding system. Inconsistent label detection in the system’s printers could result in unlabeled or mislabeled syringe preparations after compounding. Facilities should stop use of the affected sterile labels — identifiable by a white plastic overwrap backing — and revert to previously ordered non-sterile labels with a yellow backing. The FDA reported no serious injuries or deaths.
4. Thoracic stent grafts (Bolton Medical): On May 20, the FDA confirmed a Class I recall of the RelayPro Thoracic Stent Graft System in non-bare stent configurations 32mm and above. In some cases, the graft cannot be released from the delivery system because the proximal clasp disconnects from the outer control tube — a failure that cannot be detected until it occurs mid-procedure and has no device-based bailout option. The complication may require emergency conversion to open surgery. Bolton Medical is advising clinicians to consider alternative stent graft options until a fix is in place. The FDA reported three deaths, including one aortic perforation and two open surgery conversions.
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