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
K070561
Cited as predicate by: K100736
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 |
|---|---|---|---|---|
| 2026-01-15 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-01-26 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2022-12-09 | NAI | No action indicated | Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) | 0 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-07-30 | VAI | Voluntary action indicated | Teleflex LLC (NADC) | 4 |
| 2017-09-21 | NAI | No action indicated | Teleflex LLC | 0 |
| 2017-09-20 | VAI | Voluntary action indicated | Teleflex Medical, Inc. | 1 |
| 2017-02-02 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-08-29 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2015-08-13 | NAI | No action indicated | Teleflex Medical Sdn. Bhd. | 0 |
| 2015-06-05 | NAI | No action indicated | Teleflex Medical Europe Ltd | 0 |
| 2015-02-25 | NAI | No action indicated | Teleflex Medical Europe, Ltd. | 0 |
| 2014-08-28 | NAI | No action indicated | TELEFLEX LLC | 0 |
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