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Terminated

RESONATE X4 CRT-D, Model G447, Sterile.

FDA Recall Z-0081-2018 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNIK
Date Initiated2017-10-04
Date Terminated2019-10-15
Product Quantity11 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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