Z-1769-2019Class II

Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #...

Name: Z-1769-2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-10-17
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-10-17 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in... on 2018-10-17. FDA classified it as Class II and gives the reason as "An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can...". 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-1769-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Posted: 2019-06-11
Terminated: 2020-04-30
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 17, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. The letter alerted customers that the devices were assembled with stepper motors that did not meet supplier specifications. Customers were informed that in the event of a failure, the gas system flow and FiO2 control sliders on the Central Control Monitor would be disabled and the gas system could only be controlled by the local control knobs. Customers were asked to take the following actions: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using Terumo System 1 while waiting for this correction. If you have any questions, please contact Terumo CVS Customer Service: 1.800.521.2818, Monday Friday, 8 a.m. 6 p.m. ET Recall Fax: 1.734.741.6149
Quantity in commerce: 72
Distribution: Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.
Product codes and lots: 01338 01339 01340 01341 01342 01349 01350 01351 01352 01353 01354 01355 01356 01357 01358 01360 01361 01362 01363 01365 01366 01367 01369 01370 01371 01372 01373 01374 01375 01376 01377 01378 01379 Lot/Serial 01380 01381 01382 01383 01384 01385 01386 01387 01388 01389 01394 01395 01396 01397 01398 01405 01406 01407 01408 01410 01411 01413 01414 01415 01416 01418 01420 01421 01422 01423 01424 01425 01426 Lot/Serial 01427 01428 01429 01430 01431 01432 01434 01435 1718 2317 4417 9999 UDI 00886799000588

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1769-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1769-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)