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Provox Capsule 20Fr
Atos Medical AB · Model 7796 · UDI-DI 07331791009013
LRC
Prescription
10
510(k) clearances
561
Adverse events (13 deaths)
5
Recalls
221
Facilities
Description
The Provox Capsule is a single use accessory for anterograde insertion of a standard voice prosthesis by a clinician into the tracheoesophageal puncture of laryngectomized patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2013-05-24 | Gyrus Acmi, Incorporated | lack of sterility assurance |
| 2006-01-20 | Acclarent Inc | Device sterility may be compromised as evidenced by a loss of package integrity. |
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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.