EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable… recallZ-3038-2017 · Boston Scientific Corporation · initiated Jun 29, 2017
Class II Terminated All recalls posted in August 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device can deliver an atypical amount of energy due to memory corruption inside the device.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-3038-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 29, 2017
- Posted by the FDA
- Aug 16, 2017
- Recalling firm
- Boston Scientific Corporation
- Quantity
- Approximately 9,200 devices
- Product code
- LWS
- FDA submissions
- P110042
- Distribution
- Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Product description
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
Code information (models, lots, serial numbers)
All serial numbers
Other devices under the same FDA submission
10 devices cleared under P110042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- EMBLEM™ S-ICD 3401Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)5 deaths1,039 reports
- SQ-RX® PULSE GENERATOR 1010Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)3 deaths596 reports
- EMBLEM™ S-ICD 3401Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 death532 reports
- The Q-TRAK™ Subcutaneous Electrode 3400Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)2 deaths394 reports
- SQ-RX® PULSE GENERATOR 1010Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)3 deaths262 reports
- EMBLEM™ S-ICD Electrode Delivery System 4712Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 death7 reports
- EMBLEM™ S-ICD Programmer 3200Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 77803).
- Z-3037-2017 · TerminatedEMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatmen…
- Z-3039-2017 · TerminatedSQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias i…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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