# Ne oldu?
- Ne? Boston Scientific has issued a letter to affected customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold due to a potentially high-risk device issue.
- Kim? Boston Scientific and the U.S. Food and Drug Administration (FDA).
- Ne zaman? On August 24, 2024, Boston Scientific sent all affected customers a formal letter with safety recommendations.
- Nerede? Imager II catheters are used in peripheral vasculature imaging and have been distributed in the U.S. and international markets.
- Neden? The FDA has identified a potentially high-risk issue with the device. Detailed root cause analysis is not yet available to the public as the alert is in early stages.
- Nasıl? Customers are instructed to identify affected product by checking Unique Product Number (UPN) codes on both inner and outer packaging, as the codes differ.
# Şu anda bilinenler
- The Imager II Angiographic Catheters are used to create images of specific areas of interest in the peripheral vasculature.
- Boston Scientific's letter recommended "immediately stop further use or distribution and segregate affected product."
- The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
- Affected product UPN codes differ between inner and outer packaging; therefore, both codes must be checked to identify affected units.
# Sırada ne var?
- The FDA will continue its review and publish detailed findings as they become available.
- Healthcare facilities are advised to audit their inventory and remove any Imager II catheters that match the affected UPN codes.
- Boston Scientific is expected to provide a technical explanation and corrective action plan in the coming days.
- Users should closely monitor FDA updates and Boston Scientific communications for further guidance.