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Terminated

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.

FDA Recall Z-0079-2018 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNIK
Date Initiated2017-10-04
Date Terminated2019-10-15
Product Quantity4 devices

Reason for Recall

The devices have an incorrect firmware configuration.

Firm Action

The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.

Root Cause

Under Investigation by firm

Distribution Pattern

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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