Use cautionMedical device recall · FDA · Published June 8, 2021
Terumo Advanced Perfusion System 1 Gas System Recall: Intermittent Failure Risk
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801: 801188) due to intermittent failure causing blender initialization faults during calibration. Affected units may have disabled control sliders.
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
Take action
Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586
“Terumo Advanced Perfusion System 1 Gas System Recall: Intermittent Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62371-terumo-advanced-perfusion-system-1-gas-system-recall-intermittent-failure. Based on FDA recall #Z-2350-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2350-2021%22&limit=1).
The FDA announced on June 8, 2021, that Terumo Cardiovascular Systems Corporation is recalling the Terumo Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #: 801188) due to an intermittent failure hazard. The device's control sliders may become disabled during operation.
How to tell if you have it
Brand: Terumo
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System
Catalog #: 801188
Serial No.: 01751
UDI: 00886799000588
The hazard
According to the FDA, an intermittent failure causes a blender initialization fault upon start-up or during an EPGS calibration attempt following the 15-minute warm-up period. This fault disables the control sliders on the Central Control Monitor (CCM), leaving only the local control knobs for gas system control.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Draeger Atlan A350XL Anesthesia Workstation Recall (May 7, 2026), Draeger Atlan A350 Anesthesia Workstation Recall (May 7, 2026), and Draeger Vapor 3000 Anesthetic Vaporizer Recall (Nov. 24, 2025).
How to tell if you have this one
Check for the product name 'Terumo Advanced Perfusion System 1 Electronic Patient Gas System' with Catalog #801188. The serial number (S/N) starts with 01751 and the UDI is 00886799000588.
Brand
Terumo
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Ensure the control sliders on the Central Control Monitor are functional before use.
Verify Product Details
Confirm the Catalog #801188 and serial number starting with 01751 for affected units.
How this recall unfolded
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall is for a potential intermittent failure during calibration that could disable control sliders, but the device is not immediately dangerous if used correctly.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2350-2021 (June 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2350-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.