FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
- Recall number
- Z-1979-2013
- Recalling firm
- Boston Scientific CRM Corp
- Product
- Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
- Status
- Terminated
- Initiated
- 2013-07-15
- Posted
- 2013-08-16
- Terminated
- 2013-11-12
- 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
- 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
- 1 (4 devices were implanted and are not part of this action)
- Distribution
- US distribution in the state of Tennessee.
- Lot, serial or model codes
- Serial # 108063
- 510(k) numbers
- not on file
- PMA numbers
- ["P960040S235"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28