Recall Z-1445-2012 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
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.
| Date | Apr 20, 2012 (initiated Feb 24, 2012) |
| Status | Terminated |
| Reason | Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 8 |
| Distribution | Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.