Z-3038-2017Class II

EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx

Name: Z-3038-2017 EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx
Creator: Boston Scientific Corporation
Published: 2017-06-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-06-29 / Terminated / root cause: software

FDA source

Boston Scientific Corporation began a recall of EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation... on 2017-06-29. FDA classified it as Class II and gives the reason as "The device can deliver an atypical amount of energy due to memory corruption inside the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3038-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2017-08-16
Terminated: 2019-02-21
Recalling firm: Boston Scientific Corporation
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
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: The device can deliver an atypical amount of energy due to memory corruption inside the device.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: Approximately 9,200 devices
Distribution: Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3038-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3037-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15
Z-3038-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15
Z-3039-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)