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Terminated

Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Recall Z-1512-2020 · Posted 2020-03-03

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2020-02-12
Date Terminated2023-04-14
Product Quantity1 device

Reason for Recall

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

Firm Action

The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of NC, TN, and MO.

Official Source

View FDA Recall →

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

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