Z-1970-2012Class II

System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the...

Name: Z-1970-2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-25 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial... on 2012-06-25. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require...". 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-1970-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-25
Posted: 2012-07-09
Terminated: 2013-03-01
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu
Root cause tag: design
FDA root cause: Device Design
Action: Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Customer Response Form to the firm via fax at 1-800-292-6551. Contact the firm at 1-800-521-2818 for questions regarding this recall.
Quantity in commerce: 992 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Product codes and lots: catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106,1109-1445, and 1447-1450.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1970-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1971-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

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