Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. 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.
This recall has been terminated (originally issued April 20, 2012).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- February 24, 2012
- Posted
- April 20, 2012
- Terminated
- August 2, 2012
- Recall Number
- Z-1445-2012
- Quantity
- 8
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
Distribution
Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.
Lot / Code Info
219329 218900 219316 219304 219367 219372 218958 218842
Root Cause
Process control
Action Taken
The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268.