Z-1974-2013Class II

Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC

Name: Z-1974-2013 Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-07-26
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-07-26 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in... on 2013-07-26. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1974-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Posted: 2013-08-14
Terminated: 2017-02-08
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Cardiovascular Systems (TCVS) notified their consignees of the Urgent Medical Device Recall letter dated 7/26/13 and was mailed 7/29/13. The notification provided reason for the device correction, affected product, how the device will be corrected, and the potential health hazard associated with a user's inaccurate interpretation of the service pump error message. Instructions for consignee responses to the recall notice communication may be faxed to 734-741-6149 or emailed to the address on the return form. If you have any questions or concerns, call Terumo Cardiovascular Systems (TCVS) Customer Service at 1-800-521-2818 M-F, 8am-6pm ET. Terumo Cardiovascular Systems (TCVS) will provide an addendum to the APS1 Manual to their consignees. The addendum will be placed at the beginning of Chapter 6, Centrifugal Control Unit.
Quantity in commerce: 1657
Distribution: Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA
Product codes and lots: Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1974-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1973-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14
Z-1974-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)