Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270

FDA device recall Z-0917-2015 · posted 2015-01-13 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.

Action taken

Boston Scientific notified consignees on November 19, 2014, of the problem via letter through overnight delivery directing consignees to segregate and return affected product to Boston Scientific utilizing the Field Safety Corrective Action (FSCA) Instructions provided. The FSCA details that consignees should: Immediately discontinue use of and segregate product; Complete and return the Account Reply Verification Tracking form and Package/Ship the affected product.

Root cause

Device Design

Status

Terminated

Product code

NPT

Quantity affected

278 units - total all sizes

Distribution

Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.

Date initiated

2014-11-19

Date posted

2015-01-13

Date terminated

2015-03-26

Location

Los Gatos, CA