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Medtronic Inc., Cardiac Rhythm and Heart Failure
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0400-2018 | Class II | MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient imp | July 14, 2017 |
| Z-0399-2018 | Class II | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implante | July 14, 2017 |
| Z-2117-2017 | Class II | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan | April 12, 2017 |
| Z-0962-2017 | Class II | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", | December 9, 2016 |
| Z-2650-2016 | Class II | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model | August 12, 2016 |
| Z-2651-2016 | Class II | Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1 | August 12, 2016 |
| Z-2200-2016 | Class II | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) | June 16, 2016 |
| Z-2125-2016 | Class II | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, i | May 26, 2016 |
| Z-1605-2016 | Class II | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage | March 31, 2016 |