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Terminated

Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.

FDA Recall Z-1135-2012 · Posted 2012-03-01

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2012-01-19
Date Terminated2012-07-05
Product Quantity1

Reason for Recall

One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect communicator, the system reflected

Firm Action

On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.

Root Cause

Packaging process control

Distribution Pattern

Nationwide distribution: UT only.

Official Source

View FDA Recall →

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

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