FDA-Device2021-02-17Class I
EMBLEM MRI S-ICD Model A219
Hazard
Electrical overstress may lead to device malfunction.
Sold states
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Affected count
872 units
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
EMBLEM MRI S-ICD Model A219
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0951-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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