—#184935

Product

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.

FDA product code: NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P180029
Affected lot / code info: GTIN 08714729960911, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-11-17
Posted by FDA: 2021-01-09
Terminated: 2022-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.