Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 319 units of the Lotus Edge Valve System (model H749LVSUS250), a heart valve device used in transcatheter aortic valve replacement procedures. The recalled devices were distributed across 40 U.S. states, Washington D.C., and multiple countries including Canada, Australia, Japan, and several European nations. All unexpired devices with expiration dates between November 2, 2020, and October 29, 2021, are included in this recall.
The recall was issued because improper visual inspection prior to locking the valve during deployment can prevent the delivery system from being released from the patient. The source document does not specify what actions affected consumers or healthcare providers should take regarding the recalled devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distribution was made to 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, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlan Quantity: 319 devices Lot/code info: GTIN 08714729960911, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.