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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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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.

Product Detail

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