Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts
Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ICD) where a functional defect (charge time) is identified, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific CRM Corp is recalling one unit of the ENERGEN DR ICD, Model E143, an Implantable Cardioverter Defibrillator. The recall is limited to a single device with serial number 108063. Four other devices of this model were implanted but are not part of this action.
The recall was initiated after Boston Scientific's manufacturing quality system discovered test artifacts related to shock charge time in a small number of these devices. Although the devices successfully passed all manufacturing tests and met all requirements, they exhibited a slightly longer charge time than other devices during manufacturing. These findings require further investigation.
The affected device was distributed in the state of Tennessee. Patients with this specific device should contact their healthcare provider for further evaluation and instructions.
The recalled product
- Product
- Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
- Manufacturer
- Boston Scientific CRM Corp
- Category
- Medical Device — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial # 108063
Distribution
Distributed in 1 state:
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