FDA Device recall Z-1979-2013
Boston Scientific, ENERGEN DR ICD, Model E143
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of Boston Scientific, ENERGEN DR ICD, Model E143 by Boston Scientific Crm, citing boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR IC….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1979-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-15 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific Crm |
| Distribution | TN |
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Reason
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
Identifiers
| code_info | Serial # 108063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1979-2013%22
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