Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boston Scientific Recalled by Boston Scientific CRM Corp Due to Boston Scientific CRM manufacturing quality system recently discovered...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific CRM Corp directly.
Affected Products
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Quantity: 1 (4 devices were implanted and are not part of this action)
Why Was This 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
Where Was This Sold?
US distribution in the state of Tennessee.
About Boston Scientific CRM Corp
Boston Scientific CRM Corp has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report