Devices

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

Healthcare professionals must act on the issued FSNs as outlined by MHRA, ensuring compliance to address any safety concerns associated with the listed medical devices.

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

Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.

Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

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.