Z-0079-2018 Class II Terminated
FDA device recall Z-0079-2018 was initiated by Boston Scientific Corporation on October 4, 2017 and is designated Class II. Reason for recall: The devices have an incorrect firmware configuration. The recall status is terminated (terminated October 15, 2019). Affected quantity: 4 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 4, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product Description
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.
Reason for Recall
The devices have an incorrect firmware configuration.
Distribution Pattern
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Code Information
Serial numbers 174170, 174349, 174598, and 174606.