EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is in

FDA device recall Z-3037-2017 · posted 2017-08-16 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

The device can deliver an atypical amount of energy due to memory corruption inside the device.

Action taken

The firm issued notifications dated June, 2017, beginning 6/29/2017 to physicians (implanting and patient follow-up physicians) via hand delivery by their sales representatives. The firm estimated approximately 30% of the U.S. physicians would be receiving the notification via hand delivery. Hand delivery by affiliates in foreign countries to customers began approximately 6/30/2017. Overnight mail letters were issued to the U.S. and foreign physicians starting on/about 7/7/2017 who did not receive hand- delivered notifications.

Root cause

Software design

Status

Terminated

Product code

LWS

Quantity affected

Approximately 16,750 devices

Distribution

Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.

Date initiated

2017-06-29

Date posted

2017-08-16

Date terminated

2019-02-21

Location

Saint Paul, MN