CLASS II Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Terumo Advanced Perfusion System 1 Electronic Patient Gas System recalled
Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Electronic Patient Gas System. The recall was initiated on 8 Jun 2021 and the FDA has classified it as Class II.
Check your package
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-2350-2021
- FDA event ID
- 88350
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2021
- FDA classified
- 26 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Jun 2021 | Recall initiated by company | |
| 26 Aug 2021 | Classified by FDA | +79 days |
| 1 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
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 Catalog #: 801188
Where it was distributed
International distribution in the country of Panama.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
S/N: 01751 UDI: 00886799000588
Where was it sold?
International distribution in the country of Panama.
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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