Recall Z-0735-2021— Boston Scientific Corporation
Class I · Terminated
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2020-11-17, terminated 2022-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.. Reason: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-11-17
- Terminated
- 2022-01-24
- Firm location
- Maple Grove, MN, United States
Product description
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Reason for recall
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.