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Terminated

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.

FDA Recall Z-3260-2018 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2018-09-10
Date Terminated2021-09-22
Product Quantity74 units

Reason for Recall

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

Firm Action

The firm initiated the recall on 09/10/2018 to the US sales representatives by email. The sales representatives were asked to hand deliver the notice to the hospitals when the programmer is retrieved for that location. The sales representatives will electronically confirm the hand delivery of the letter to each affected customer after it occurs.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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