PlainRecalls
FDA Devices Critical Class I Terminated

EMBLEM S-ICD Model A209

Reported: February 17, 2021 Initiated: December 2, 2020 #Z-0950-2021

Product Description

EMBLEM S-ICD Model A209

Reason for Recall

Electrical overstress may lead to device malfunction.

Details

Units Affected
1953 units
Distribution
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
EMBLEM S-ICD Model A209. Recalled by Boston Scientific Corporation. Units affected: 1953 units.
Why was this product recalled?
Electrical overstress may lead to device malfunction.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 17, 2021. Severity: Critical. Recall number: Z-0950-2021.