# Ne oldu?

The U.S. Food and Drug Administration (FDA) has issued an Early Alert notifying that Boston Scientific's Imager II Angiographic Catheters may present a high-risk issue. In response, Boston Scientific has sent a letter to affected customers recommending that all units be removed from use or sale immediately.

# Ayrıntılar

The manufacturer's directive includes several critical steps for healthcare facilities. Users are advised to immediately stop further use or distribution of the affected product and segregate the devices. To identify affected units, facilities must verify inventory using the Unit Package Number (UPN) codes found on both the inner and outer packaging. Additionally, affected customers are required to complete and return the enclosed Reply Verification Tracking Form (RVTF) for any returned units. The FDA is currently reviewing the information and will keep the public informed as significant new information becomes available.

# Neden önemli?

This action is significant because angiographic catheters are essential tools used in cardiac and vascular procedures. A high-risk issue with these devices could potentially impact patient safety during critical interventions. The urgency of the recall underscores the need for immediate inventory verification and compliance with the manufacturer's and FDA's directives to prevent potential adverse events.

# Sırada ne var?

The FDA will continue to monitor the situation and provide updates as more information becomes available. Healthcare facilities should remain vigilant and ensure all Imager II Angiographic Catheters in their inventory are accounted for and handled according to the recommended protocols.

# # Source

Early Alert: Angiographic Catheter Issue from Boston Scientific | FDA https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-angiographic-catheter-issue-boston-scientific