Boston Scientific — Class II medical device recall Z-1979-2013
Terminated recall by Boston Scientific CRM Corp, reported 2013-08-28, distributed in TN. Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge
| Recall number | Z-1979-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific CRM Corp, Saint Paul, MN, United States |
| Recall initiated | 2013-07-15 |
| Classified | 2013-08-16 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2013-11-12 |
| Distributed | TN |
| Serial numbers | 108063 |
| Model numbers | E143 |
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1979-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.