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VenSure Balloon Dilation System
Fiagon GmbH · Model 1 · UDI-DI 04260759931246
10
510(k) clearances
561
Adverse events (13 deaths)
5
Recalls
220
Facilities
Description
Balloon Dilation system as set including Balloon dilation device with bending tool and Inflation device with tubes,
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.