Class 1 Device Recall Lotus Edge Valve System

• Date Initiated by Firm: November 17, 2020
• Date Posted: January 09, 2021
• Recall Status: Terminated on January 24, 2022
• Recall Number: Z-0736-2021
• Recall Event ID: 86947
• PMA Number: P180029
• Product Classification: Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
• Product: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
• Code Information: GTIN 08714729940838, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Nicole Pshon; 763-494-1700
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: The recalling firm issued a press release on 11/17/2020, as well as letters dated 11/17/2020 issued via overnight mail delivery to the U.S. direct account medical facilities and clinical investigators. OUS customers were also issued the letter on 11/17/2020 through various methods, including email, courier, hand-delivery, and phone. The letter was flagged "Medical Device Recall-Immediate Action Required" and said BSC was conducting a removal of the unused inventory and there was no safety issue for patients who previously received the valve. The letter explained the details surrounding the reason for removal from the field. Regarding actions to be taken by the customer, BSC recommended that patients who have the device continue with their routine follow-up care and no additional action is needed for them. Further distribution or use of the remaining product was to be ceased immediately. The product was to be immediately segregated and returned to Boston Scientific per their enclosed instructions. If the customer was a distributor, they were instructed to forward the notification to their customers as the recall was to the hospital level. A Reply Verification Tracking Form was enclosed to be completed and returned via email or FAX even if the customer no longer has any of the devices.
• Quantity in Commerce: 386 devices
• 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, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NPT and Original Applicant = Boston Scientific Corporation