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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Recall Number Z-1979-2013
Classification Class II
Code Info Serial # 108063
Product Distributed Qty 1 (4 devices were implanted and are not part of this action)
Reason For Recall 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 manufacturing test.

Event Detail

Event Id 65798
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific CRM Corp
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US distribution in the state of Tennessee.
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