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
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 |
|---|---|---|---|---|
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2011-10-04 | WL | Warning Letter | Oridion Medical 1987 Ltd. | — |
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