—#180032

Product

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 product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960040S306
Affected lot / code info: Serial Number 516959

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

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

Timeline

Recall initiated: 2020-02-12
Posted by FDA: 2020-03-03
Terminated: 2023-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.