FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: RESONATE EL ICD VR, Model D432, Sterile.
- Recall number
- Z-0077-2018
- Recalling firm
- Boston Scientific Corporation
- Product
- RESONATE EL ICD VR, Model D432, Sterile.
- Status
- Terminated
- Initiated
- 2017-10-04
- Posted
- not on file
- Terminated
- 2019-10-15
- Reason
- The devices have an incorrect firmware configuration.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.
- Quantity
- 5 devices
- Distribution
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Serial numbers 224020, 224209, 224322, 224366, and 224506
- 510(k) numbers
- not on file
- PMA numbers
- ["P960040"]
- 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