Recall Z-0879-2021— Boston Scientific Corporation
Class I · Terminated
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2020-11-13, terminated 2024-07-23. FDA's recall record names no specific 510(k) clearance for this event. Product: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD). Reason: There is potential for fractures which results in the inability to delivery therapy..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-11-13
- Terminated
- 2024-07-23
- Firm location
- Saint Paul, MN, United States
Product description
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Reason for recall
There is potential for fractures which results in the inability to delivery therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.