Z-3242-2018Class II

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures...

Name: Z-3242-2018 Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-08-28
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-08-28 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763 on 2018-08-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3242-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-28
Posted: 2018-09-25
Terminated: 2020-04-23
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Terumo CVS issued letter on 8/2/818 via Fed'X 2 day air to inform users of the problem for the Power Manager boards with unverifiable or out of specification screws, potential hazard and field correction. A Terumo Field Service Representative will contact users to schedule the field correction activities. Terumo CVS Customer Service: 1.800.521.2818, Monday Friday, 8 a.m. 6 p.m. ET
Quantity in commerce: 47 units
Distribution: Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3242-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3242-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25
Z-3243-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25

Product code DTQ

K172220Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)