Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0735-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Product Classification:

Class I

Date Initiated: November 17, 2020

Date Posted: January 20, 2021

Recall Number: Z-0735-2021

Event ID: 86947

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.

Status: Terminated

Product Quantity: 278 devices

Code Information:

GTIN 08714729940821, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021

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.

Voluntary or Mandated:

Voluntary: Firm initiated