EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Reported: August 30, 2023 Initiated: July 11, 2023 #Z-2441-2023
Product Description
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Reason for Recall
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 3,856 units
- Distribution
- Worldwide
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator. Recalled by Boston Scientific Corporation. Units affected: 3,856 units.
Why was this product recalled? ▼
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2441-2023.
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