Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS

FDA device recall Z-0729-2021 · posted 2021-01-09 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

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.

Root cause

Device Design

Status

Terminated

Product code

NPT

Quantity affected

319 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 distribu

Date initiated

2020-11-17

Date posted

2021-01-09

Date terminated

2022-01-24

Location

Maple Grove, MN