Terumo Advanced Perfusion System 1 recallZ-2350-2021 · Terumo Cardiovascular Systems Corporation · initiated Jun 8, 2021
Terminated
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 Terumo Cardiovascular Systems Corporation 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
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
FDA root cause category: Nonconforming Material/Component
What the company is doing
Terumo notified the regional affiliate to address the single EPGS device in Panama via email on 6/8/21. Letter states reason for recall, health risk and action to take: Terumo CVS will execute a field correction to replace the one (1) affected EPGS device. A Terumo Representative will contact you to schedule the field correction activities. 1. Review this Medical Device Correction and assure the user has received notice of this issue. 2. A Terumo representative will contact the user to schedule the field correction activity. Note: Terumo CVS recommends that users continue using the affected Terumo System 1 while waiting for this correction. We encourage you to contact your local Terumo representative with any questions or concerns.
Recall details
- Recall number
- Z-2350-2021
- Status
- Terminated
- Initiated by the company
- Jun 8, 2021
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 1 unit OUS
- Product code
- DTQ
- FDA submissions
- K172220
- Distribution
- International distribution in the country of Panama.
Product description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Code information (models, lots, serial numbers)
S/N: 01751 UDI: 00886799000588
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
Product lines
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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