—#157928

Product

EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: All serial numbers

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

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

Timeline

Recall initiated: 2017-06-29
Posted by FDA: 2017-08-16
Terminated: 2019-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.