FDA recall Z-3260-2018

Product

Model 3300 LATITUDE(TM) Programming System 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.

Reason for recall

There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

Distribution

Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland

Key facts

Status

Terminated

Initiation date

2018-09-10

Report date

2018-10-03

Termination date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3260-2018