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Provox BasePlate Adaptor
Atos Medical AB · Model 7263 · UDI-DI 07331791001697
1
510(k) clearances
15,021
Adverse events (164 deaths)
131
Recalls
74
Facilities
Description
The Provox BasePlate Adaptor is an accessory product for rehabilitation after total laryngectomy. It allows attaching medical devices with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-15 | Covidien LLC | Due to customer complaint regarding incorrect display box labeling. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-02-26 | Covidien | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspeci |
| 2023-08-22 | Smiths Medical ASD Inc. | The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026). |
| 2023-04-07 | Cook Incorporated | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. |
| 2023-04-07 | Cook Incorporated | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. |
| 2023-03-24 | Covidien | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15m |
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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.