CLASS II Device recall · Reported 19 Jun 2019 · FDA Enforcement Report

Terumo Advanced Perfusion System 1 Electronic Patient Gas recalled

Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas, distributed nationwide in the US. The recall was initiated on 17 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes01338 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

Quantity recalled72

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1769-2019
FDA event ID: 82878
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2018
FDA classified: 11 Jun 2019
Reported: 19 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 Oct 2018	Recall initiated by company
11 Jun 2019	Classified by FDA	+237 days
19 Jun 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.

Where it was distributed

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.

Nationwide California Connecticut Illinois Indiana Kentucky Michigan Minnesota Missouri Montana New Mexico New York Ohio Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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