with Notch 22M/15F sold as part of Breas Medical MPV… recallZ-0405-2024 · Breas Medical, Inc. · initiated Oct 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Breas Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
FDA root cause category: Process control
What the company is doing
Breas Medical contacted customers via telephone followed by email on 10/13/23. Letter (Breas reference: SCAR-330) states reason for recall, health risk and action to take: Breas Medical recommends that all those potentially affected by this notice inspect existing inventory and identify mouthpieces which have been set up with the Vivo 45 LS for patient use. All defective mouthpieces shall be discarded. Breas Medical will provide replacement NIV Angled Mouthpieces, article number 008234, for all defective inventory and for devices in patient possession, where applicable. To obtain replacement NIV Angled Mouthpieces, we are asking customers to identify mouthpieces delivered from Breas since April 4, 2023 and complete the response form. We kindly ask you to acknowledge receipt of this Field Safety Notice together with your choice to remedy the issue using attached reply form NIV Angled Mouthpiece Field Safety Notice Distributor/Customer Reply Form. Contact Information Email: [email protected] Helpline: +1 (855) 436-8724 Postal Address 16 Esquire Road, N. Billerica, MA 01862 Web Portal: breas.com
Recall details
- Recall number
- Z-0405-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2023
- Posted by the FDA
- Nov 27, 2023
- Recalling firm
- Breas Medical, Inc.
- Quantity
- 215 units
- Product code
- NOU
- FDA submissions
- K193586, K233452
- Distribution
- Nationwide Foreign: Canada
Product description
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
Code information (models, lots, serial numbers)
UDI-DI: 05030267120505 NIV Angled Mouthpiece with Notch 22M/15F; 07321820060931 MPV Kit 006093; 07321820066537 MPV Kit 006653 MPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F 1938000Intersurgical Incorporated · Mouthpiece, Breathing1 recall0 reports
- Vivo Series 006093Breas Medical AB · Set, Tubing And Support, Ventilator (W Harness)1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K193586, K233452 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vivo 45 LS USBreas Medical AB · Ventilator, Continuous, Facility Use2 recalls6 deaths13 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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