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Venner™ PneuX P.Y.™ TT MRI
VENNER MEDICAL (SINGAPORE) PTE. LTD. · Model 902180 · UDI-DI 08885009190837
10
510(k) clearances
6,588
Adverse events (163 deaths)
73
Recalls
75
Facilities
Description
The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space. It is also safety in an MRI environment (indicated MRI).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | Covidien LLC | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
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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.