EMBLEM S-ICD Subcutaneous Electrode recall
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Why was EMBLEM S-ICD Subcutaneous Electrode recalled?
There is potential for fractures which results in the inability to delivery therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
- Product
- EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 47000 units
- Distribution
- Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
- Recall date
- January 27, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)