Resonate EL ICD DR recall
RESONATE EL ICD DR, Model D433, Sterile.
Why was Resonate EL ICD DR recalled?
The devices have an incorrect firmware configuration.
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?
Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.
- Product
- RESONATE EL ICD DR, Model D433, Sterile.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 12 devices
- Distribution
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)