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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- November 17, 2020
- Posted
- January 9, 2021
- Terminated
- January 24, 2022
- Recall Number
- Z-0729-2021
- Quantity
- 319 devices
- Firm Location
- Maple Grove, MN
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, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.
Lot / Code Info
GTIN 08714729960911, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
Root Cause
Device Design
Action Taken
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.