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Terminated

Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

FDA Recall Z-1979-2013 · Posted 2013-08-16

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2013-07-15
Date Terminated2013-11-12
Product Quantity1 (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 manufactu

Firm Action

Consignee 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.

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution in the state of Tennessee.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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