Boston Scientific CRM Corp
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0087-2015 | Class II | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. | September 17, 2014 |
| Z-0088-2015 | Class II | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models | September 17, 2014 |
| Z-2147-2014 | Class II | Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile | June 19, 2014 |
| Z-0026-2014 | Class II | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models | August 29, 2013 |
| Z-0025-2014 | Class II | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. | August 29, 2013 |
| Z-1979-2013 | Class II | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillat | July 15, 2013 |
| Z-1339-2013 | Class II | LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management sys | April 10, 2013 |
| Z-0965-2013 | Class II | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is | March 1, 2013 |