—#183949

Product

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P910077S178
Affected lot / code info: Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751

Why it was recalled

There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.

Root cause (FDA determination)

Software design

Action the firm took

Boston Scientific sales representatives will hand-deliver a removal letter to all customer consignees with one of the eight affected Model 3300 LATITUDE programmer. BSC sales representatives will maintain control of these devices. In order to continue to provide the benefits that this software support application provides for those patients implanted with an ALTRUA/INSIGNIA I pacemaker, BSC sales representatives will continue to use Model 3300 LATITUDE programmers installed with the Model 3892 v1.04 ALTRUA / INSIGNIA I / NEXUS I Software Support Application in the field. The risks associated with this unintended behavior can be avoided when specific remedial actions are adhered to. These remedial actions will be adhered to until a software correction is approved and installed on these programmers. BSC will confirm via email from sales representatives that 100% of the removal letters were delivered. BSC will post the removal letter on the BSC website within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html.

Recalling firm

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

Distribution

Distribution pattern: Distributed in US - AR, FL, IL, and TX

Timeline

Recall initiated: 2020-09-22
Terminated: 2024-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.