LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management ...
FDA Device Recall #Z-1339-2013 — Class II — April 10, 2013
Recall Summary
| Recall Number | Z-1339-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific CRM Corp |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 1 |
Product Description
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Reason for Recall
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
Distribution Pattern
Nationwide Distribution including DC and PR
Lot / Code Information
n/a
Other Recalls from Boston Scientific CRM Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0087-2015 | Class II | Boston Scientific COGNIS CRT-D, Cardiac Resynch... | Sep 17, 2014 |
| Z-0088-2015 | Class II | Boston Scientific TELIGEN, Implantable Cardiac ... | Sep 17, 2014 |
| Z-2147-2014 | Class II | Boston Scientific ENDOTAK RELIANCE¿ SG, transve... | Jun 19, 2014 |
| Z-0026-2014 | Class II | Boston Scientific TELIGEN, Implantable Cardiac ... | Aug 29, 2013 |
| Z-0025-2014 | Class II | Boston Scientific COGNIS CRT-D, Cardiac Resynch... | Aug 29, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.