Z-1979-2013Class II

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

Name: Z-1979-2013 Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator
Creator: Boston Scientific CRM Corp
Published: 2013-07-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-07-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator on 2013-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1979-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Posted: 2013-08-16
Terminated: 2013-11-12
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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
Root cause tag: manufacturing process
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1 (4 devices were implanted and are not part of this action)
Distribution: US distribution in the state of Tennessee.
Product codes and lots: Serial # 108063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1979-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1979-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-16

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)