Safety Signals

Clinics and healthcare facilities are required to verify their inventory immediately and isolate any affected units to prevent accidental use.

Users must ensure systems remain connected to power, conduct proper startup procedures, perform preoperative checks, and have emergency ventilation plans in place. Acknowledgment of receipt of the safety notice is required within 30 days.

Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.

Update local protocols to ensure parenteral nutrition is administered with filters in compliance with the new requirements.

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.