Boston Scientific recall
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Why was Boston Scientific recalled?
Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu
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 # 108063
- Product
- Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
- Recalling firm
- Boston Scientific CRM Corp
- Quantity
- 1 (4 devices were implanted and are not part of this action)
- Distribution
- US distribution in the state of Tennessee.
- Recall date
- August 28, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)