FDA Medical Device Recalls (openFDA)
Ventus Medical, Inc.: The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
- Recall number
- Z-2435-2010
- Recalling firm
- Ventus Medical, Inc.
- Product
- The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
- Status
- Terminated
- Initiated
- 2009-12-03
- Posted
- 2010-09-19
- Terminated
- 2011-03-11
- Reason
- The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient .
- Root cause
- Labeling mix-ups
- Action
- Ventus Medical, Inc. of Belmont, CA has notified all customers who received distribution from the affected manufacturing lot (1880783) to immediately return the product in question for replacement. If there are any questions regarding this correction, please contact the firm at (650) 632-4165.
- Quantity
- 60
- Distribution
- Product was distributed in the US through a single distribution supplier.
- Lot, serial or model codes
- Catalog Number: MRS0208 Lot Number: 1880783
- 510(k) numbers
- ["K080983"]
- PMA numbers
- not on file
- Product code
- MNR
- Firm FEI
- 3007038487
- Firm city
- Belmont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28