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
Predicate lineage
K040758
Cited as predicate by: K103656
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-23 | WL | Warning Letter | Abbott Diabetes Care, Inc. | — |
| 2025-12-10 | NAI | No action indicated | Alere San Diego Inc. | 0 |
| 2025-10-23 | OAI | Official action indicated | Abbott Diabetes Care, Inc. | 2 |
| 2025-09-19 | NAI | No action indicated | Abbott Medical | 0 |
| 2025-05-30 | VAI | Voluntary action indicated | Thoratec LLC | 2 |
| 2025-05-15 | NAI | No action indicated | St Jude Cardiology Division Incorporated | 0 |
| 2025-02-21 | NAI | No action indicated | Abbott Medical | 0 |
| 2024-09-19 | NAI | No action indicated | Abbott Point of Care Canada Limited | 0 |
| 2024-08-16 | NAI | No action indicated | Ameditech Inc | 0 |
| 2024-08-13 | NAI | No action indicated | St. Jude Medical | 0 |
| 2024-06-28 | VAI | Voluntary action indicated | Abbott | 3 |
| 2024-04-25 | NAI | No action indicated | Abbott Medical Costa Rica Ltda | 0 |
| 2023-12-08 | NAI | No action indicated | Abbott Vascular | 0 |
| 2023-11-16 | OAI | Official action indicated | Abbott Vascular | 0 |
| 2023-11-16 | NAI | No action indicated | Abbott Diabetes Care, Inc. | 0 |
| 2023-10-27 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2023-06-28 | VAI | Voluntary action indicated | Abbott Medical | 3 |
| 2023-03-21 | VAI | Voluntary action indicated | BIGFOOT BIOMEDICAL | 2 |
| 2023-01-27 | VAI | Voluntary action indicated | Abbott Molecular, Inc. | 2 |
| 2022-12-14 | NAI | No action indicated | Cardiovascular Systems Inc | 0 |
| 2022-11-23 | VAI | Voluntary action indicated | Abbott Medical | 1 |
| 2022-11-08 | WL | Warning Letter | Abbott Point of Care Canada Limited | — |
| 2017-04-12 | WL | Warning Letter | Abbott Medical | — |
| 2015-09-30 | WL | Warning Letter | St. Jude Medical | — |
| 2013-01-10 | WL | Warning Letter | Abbott Medical | — |
| 2012-10-10 | WL | Warning Letter | Alere San Diego, Inc. | — |
| 2012-06-05 | WL | Warning Letter | St. Jude Medical | — |
| 2012-01-03 | WL | Warning Letter | Thoratec LLC | — |
| 2010-12-22 | WL | Warning Letter | Abon Biopharm (Hangzhou) Co., Ltd. | — |
| 2010-07-02 | WL | Warning Letter | Abbott Diabetes Care, Inc. | — |
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