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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-01-15NAINo action indicatedTeleflex Medical OEM LLC0
2024-03-18NAINo action indicatedTeleflex LLC (NADC)0
2024-03-18NAINo action indicatedTeleflex LLC (NADC)0
2024-01-26NAINo action indicatedTeleflex Medical OEM LLC0
2022-12-09NAINo action indicatedTeleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company)0
2022-08-26VAIVoluntary action indicatedTELEFLEX LLC3
2022-08-26VAIVoluntary action indicatedTELEFLEX LLC3
2021-09-02NAINo action indicatedTELEFLEX LLC0
2021-09-02NAINo action indicatedTELEFLEX LLC0
2021-07-30VAIVoluntary action indicatedTeleflex LLC (NADC)4
2017-09-21NAINo action indicatedTeleflex LLC0
2017-09-20VAIVoluntary action indicatedTeleflex Medical, Inc.1
2017-02-02NAINo action indicatedTeleflex Medical OEM LLC0
2016-08-29NAINo action indicatedTeleflex Medical OEM LLC0
2016-03-03NAINo action indicatedTeleflex LLC (NADC)0
2016-03-03NAINo action indicatedTeleflex LLC (NADC)0
2015-08-13NAINo action indicatedTeleflex Medical Sdn. Bhd.0
2015-06-05NAINo action indicatedTeleflex Medical Europe Ltd0
2015-02-25NAINo action indicatedTeleflex Medical Europe, Ltd.0
2014-08-28NAINo action indicatedTELEFLEX LLC0
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