FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
- Recall number
- Z-0079-2018
- Recalling firm
- Boston Scientific Corporation
- Product
- VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
- 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
- 4 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 174170, 174349, 174598, and 174606.
- 510(k) numbers
- not on file
- PMA numbers
- P960040, P010012
- Product code
- NIK
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06