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Provox® Vega™ XtraSeal™
Atos Medical AB · Model 20 Fr · UDI-DI 07331791010477
EWL
Prescription
1
510(k) clearances
174
Adverse events (3 deaths)
4
Recalls
5
Facilities
Description
Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis.
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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Get your free API keyRead the docsData 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.