EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Reported: February 3, 2021 Initiated: December 2, 2020 #Z-0936-2021
Product Description
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Reason for Recall
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 11296 units
- Distribution
- worldwide
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219. Recalled by Boston Scientific Corporation. Units affected: 11296 units.
Why was this product recalled? ▼
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0936-2021.
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