Z-2350-2021Class II

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Name: Z-2350-2021 Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Creator: Terumo Cardiovascular Systems Corporation
Published: 2021-06-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2021-06-08 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 on 2021-06-08. FDA classified it as Class II and gives the reason as "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...". 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-2350-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-08
Posted: 2021-08-26
Terminated: 2022-06-28
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1 unit OUS
Distribution: International distribution in the country of Panama.
Product codes and lots: S/N: 01751 UDI: 00886799000588

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2350-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2350-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)