CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
Terumo 100/120V AC, Advanced Perfusion System Platform recalled
Terumo Cardiovascular Systems is recalling Terumo 100/120V 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-3242-2018
- 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 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
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: 0386 1481 1497 1509 1526 1529 1531 1532 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1561 1562 1563 1564 1565 1566 1570 1597 1612 1630 1631 1640 1641 1649 1547 1560 1559 1567 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03130 , 03308
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 80957This product is part of a recall event; the main page for the event is Terumo 220/240V AC, Advanced Perfusion System Platform recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terumo 220/240V AC, Advanced Perfusion System Platform recalled | Terumo Cardiovascular Systems | Other | Nationwide |
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