medical Class I Updated 2021-01-20

Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthes

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV

Lot/Code Info: GTIN 08714729940821, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

View official government recall

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