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U.S. Department of Health and Human Services

Class 2 Device Recall ENERGEN DR ICD

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 Class 2 Device Recall ENERGEN DR ICDsee related information
Date Initiated by FirmJuly 15, 2013
Date PostedAugust 16, 2013
Recall Status1 Terminated 3 on November 12, 2013
Recall NumberZ-1979-2013
Recall Event ID 65798
PMA NumberP960040S235 
Product Classification implantable cardioverter defibrillator (non-crt) - Product Code LWS
ProductBoston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Code Information Serial # 108063
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer 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 manufactu
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignee was sent on 7/15/13 a Boston Scientific "Medical Device Retrieval" letter dated July 12. 2013. The letter described the product problem and informed the consignee that they will replace the product removed from their inventory. For further questions, contact Boston Scientific Technical Services at 1 800 227-3422.
Quantity in Commerce1 (4 devices were implanted and are not part of this action)
DistributionUS distribution in the state of Tennessee.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LWS
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