Recall Z-0936-2021— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-12-02. FDA's recall record names no specific 510(k) clearance for this event. Product: EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219. Reason: Accelerated battery depletion may result in a need for device replacement earlier than expected..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-12-02
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.