—#180031

Product

Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P910077S159
Affected lot / code info: Serial Numbers: 008885, 010823, 010615, 007886

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 #180031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.