| Class 2 Device Recall Latitude Patient Management System Communicator | |
Date Initiated by Firm | February 24, 2012 |
Date Posted | April 20, 2012 |
Recall Status1 |
Terminated 3 on August 02, 2012 |
Recall Number | Z-1445-2012 |
Recall Event ID |
61390 |
PMA Number | P910077 |
Product Classification |
Implantable cardioverter defibrillator (non-crt) - Product Code LWS
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Product | 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. |
Code Information |
219329 218900 219316 219304 219367 219372 218958 218842 |
Recalling Firm/ Manufacturer |
Boston Scientific CRM Corp 4100 Hamline Ave N Saint Paul MN 55112-5700
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For Additional Information Contact | 651-582-4000 |
Manufacturer Reason for Recall | Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients. |
FDA Determined Cause 2 | 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 in Commerce | 8 |
Distribution | Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LWS
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