CLASS II Device recall · Reported 22 May 2019 · 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, distributed nationwide in the US. The recall was initiated on 18 Apr 2019 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-1337-2019
- FDA event ID
- 82630
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2019
- FDA classified
- 15 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 18 Apr 2019 | Recall initiated by company | |
| 15 May 2019 | Classified by FDA | +27 days |
| 22 May 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Product as listed by the FDA
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
Questions about this recall
Why was it recalled?
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Which lots are affected?
All
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
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.
More recalls from Terumo Cardiovascular Systems
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|---|---|---|---|---|---|
| Device | CLASS II | CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems | Terumo Cardiovascular Systems | Labeling Errors | Nationwide |
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| Device | CLASS II | Cardiovascular Procedure Kits that include High Crack Check recalled | Terumo Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Capiox RX15 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Capiox FX25 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
Other Patient Monitors recalls
All 1,014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |