Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system

FDA device recall Z-1135-2012 · posted 2012-03-01 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

1

Distribution

Nationwide distribution: UT only.

Date initiated

2012-01-19

Date posted

2012-03-01

Date terminated

2012-07-05

Location

Saint Paul, MN