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Provox Vega Puncture Set 20Fr 10mm

Atos Medical AB · Model 8145US · UDI-DI 07331791009136

EWL Prescription

510(k) clearances

176

Adverse events (3 deaths)

Recalls

Facilities

Description

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.

Recalls

Date	Firm	Reason
2026-06-17	Freudenberg Medical, LLC	Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang
2026-06-17	Freudenberg Medical, LLC	Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang
2013-10-01	Helix Medical LLC	InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATS
2012-03-08	Helix Medical LLC	Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.