Terumo Advanced Perfusion System 1 recallZ-1478-2018 · Terumo Cardiovascular Systems Corporation · initiated Jan 19, 2018
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
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
FDA root cause category: Employee error
What the company is doing
The firm notified customers via phone alerting them of this affected device, issue, potential hazard, correction, and instructions. The communication also included scheduling an expedited service call for a Field Service Technician to replace the affected Flowmeter Module with a corrected Flowmeter Module. When necessary to avoid delaying or cancelling life-sustaining surgery, users can continue to use the Flowmeter Module while awaiting replacement. Once the issue is recognized by the user, if a replacement Flowmeter Module is available, replacement and reassignment of safety connections of the Flowmeter Module can be accomplished in less than 15 seconds. In the event that a replacement Flowmeter Module is not available, a less common mitigation is the use of a back-up stand-alone centrifugal pump or a stand-alone ultrasonic flowmeter system to provide flow data. Customers should receive a copy of the Urgent Medical Device Recall phone script by e-mail along with a Customer Response Form. The e-mail should be reviewed, and the form completed and returned as indicated. Questions or concerns can be directed Terumo CVS Customer Service at 1-800-521-2818.
Recall details
- Recall number
- Z-1478-2018
- Status
- Terminated
- Initiated by the company
- Jan 19, 2018
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 7
- Product code
- DTQ
- FDA submissions
- K172220
- Distribution
- Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Product description
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Code information (models, lots, serial numbers)
Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.
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 802018Terumo Cardiovascular Systems Corporation · Pump, Blood, Cardiopulmonary Bypass, Roller Type1 recall1 death46 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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