Recall – Implantable pulse generator trace may flatline

Company: Boston Scientific Corporation
Date of Enforcement Report: 11/11/2020
Class II

PRODUCT

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

Recall Number: Z-0319-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Boston Scientific Corporation on 9/22/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

8 devices

DISTRIBUTION

U.S. Nationwide

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

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