# FDA recall Z-2543-2019

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-08-21.

## Product

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

## Reason for recall

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

## Distribution

Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming.      International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, , Lithuania, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovaki

## Key facts

- **Recall number:** Z-2543-2019
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-21
- **Report date:** 2019-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2019

## Citation

> AI Analytics. FDA recall Z-2543-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2543-2019. Source: US FDA. Licensed CC0.

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