Recall Z-0951-2021— Boston Scientific Corporation
Class I · Terminated
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2020-12-02, terminated 2022-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: EMBLEM MRI S-ICD Model A219. Reason: Electrical overstress may lead to device malfunction..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-12-02
- Terminated
- 2022-06-23
- Firm location
- Saint Paul, MN, United States
Product description
EMBLEM MRI S-ICD Model A219
Reason for recall
Electrical overstress may lead to device malfunction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.