CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
Terumo 220/240V AC, Advanced Perfusion System Platform recalled
Terumo Cardiovascular Systems is recalling Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary, distributed nationwide in the US. The recall was initiated on 28 Aug 2018 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-3243-2018
- FDA event ID
- 80957
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2018
- FDA classified
- 25 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +28 days |
| 3 Oct 2018 | 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
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Product as listed by the FDA
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Where it was distributed
Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Questions about this recall
Why was it recalled?
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Which lots are affected?
Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
Where was it sold?
Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
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.
Other products in this recall event
1 other product · FDA event 80957| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terumo 100/120V AC, Advanced Perfusion System Platform recalled | Terumo Cardiovascular Systems | Other | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |