Z-1478-2018Class II

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow...

Name: Z-1478-2018 Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-01-19
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-01-19 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system on 2018-01-19. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1478-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Posted: 2018-04-20
Terminated: 2018-07-18
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 7
Distribution: Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Product codes and lots: Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code DTQ

K172220Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)