Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K153160Substantially equivalent (SESE) · 2016-03-30clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-27 | NAI | No action indicated | SPR Therapeutics Inc. | 0 |
| 2026-02-06 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2025-12-15 | VAI | Voluntary action indicated | MEDTRONIC GRAND RAPIDS | 2 |
| 2025-11-11 | VAI | Voluntary action indicated | Scientia Vascular, Inc. | 1 |
| 2025-03-14 | NAI | No action indicated | Medtronic Puerto Rico Operations Co. | 0 |
| 2025-02-10 | VAI | Voluntary action indicated | Medtronic, Inc. | 1 |
| 2025-02-10 | VAI | Voluntary action indicated | Medtronic, Inc. | 1 |
| 2024-12-05 | NAI | No action indicated | Medtronic Powered Surgical Solutions | 0 |
| 2024-10-31 | VAI | Voluntary action indicated | Medtronic CryoCath LP | 1 |
| 2024-08-09 | NAI | No action indicated | Medtronic, Inc. | 0 |
| 2024-08-09 | NAI | No action indicated | Medtronic, Inc. | 0 |
| 2024-06-17 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2024-06-11 | VAI | Voluntary action indicated | Medtronic Navigation, Inc.-Boxborough | 2 |
| 2024-02-09 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 3 |
| 2024-02-01 | NAI | No action indicated | MEDTRONIC CARE MANAGEMENT SERVICES | 0 |
| 2024-01-03 | NAI | No action indicated | Medtronic MiniMed, Inc. | 0 |
| 2023-09-01 | NAI | No action indicated | Medtronic, Inc. | 0 |
| 2023-09-01 | NAI | No action indicated | Medtronic, Inc. | 0 |
| 2023-05-05 | VAI | Voluntary action indicated | Medtronic Neuromodulation | 4 |
| 2023-03-10 | VAI | Voluntary action indicated | Medtronic MiniMed, Inc. | 3 |
| 2021-12-09 | WL | Warning Letter | Medtronic MiniMed, Inc. | — |
| 2018-08-23 | WL | Warning Letter | Medtronic Puerto Rico Operations Co. | — |
| 2018-07-30 | WL | Warning Letter | Medtronic, Inc. | — |
| 2018-07-30 | WL | Warning Letter | Medtronic, Inc. | — |
| 2015-04-29 | INJ | Injunction | Medtronic Neuromodulation | — |
| 2014-06-02 | WL | Warning Letter | Heartware, Inc. | — |
| 2013-09-19 | WL | Warning Letter | Medtronic MiniMed, Inc. | — |
| 2012-07-17 | WL | Warning Letter | Medtronic Neuromodulation | — |
| 2010-05-07 | WL | Warning Letter | Medtronic Navigation, Inc. | — |
| 2009-11-09 | WL | Warning Letter | Medtronic, Inc. | — |
Similar devices
- INFINITY M300 Nellcor WPA2 DRAEGER MEDICAL SYSTEMS, INC.
- """VitalPatch™ Active Patch" Vital Connect, Inc.
- """VitalPatch™ Gentle Patch" Vital Connect, Inc.
- "19""""display(adapter/5M)" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "22""""display(adapter/5M)" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-LEAD,ECG,UNIV,SNAP,18"",INT'L" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-LEAD,ECG,UNIV,SNAP,18"",USA" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-LEAD,ECG,UNIV,SNAP,24"",INT'L" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-LEAD,ECG,UNIV,SNAP,36"",AAMI" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-LEAD,ECG,UNIV,SNAP,36"",INT'L" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-Lead,ECG,Univ,Pinch,18"",AAMI" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- "3-Lead,ECG,Univ,Pinch,18"",IEC" Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Select up to two to place side-by-side with this device.