Z-3243-2018Class II

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures...

Name: Z-3243-2018 Terumo 220/240V 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 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764 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-3243-2018
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 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
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: 10 units
Distribution: Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3243-2018
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)