Terumo Advanced Perfusion System 1 recallZ-1769-2019 · Terumo Cardiovascular Systems Corporation · initiated Oct 17, 2018
Class II 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
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.
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-1769-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2018
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 72
- Product code
- DTQ
- FDA submissions
- K172220
- 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 description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Code information (models, lots, serial numbers)
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
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 18, 2026. Text above is shown as published by the FDA.
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