Z-2009-2012Class II

Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is...

Name: Z-2009-2012 Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-21 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal... on 2012-06-21. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single...". 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-2009-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-21
Posted: 2012-07-13
Terminated: 2013-06-10
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 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 has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 21, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Recall notice. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/ email address indicated on the form. Terumo CVS Customer Service-1-800-521-2818 Fax-1-800-292-6551. Customer Service Hours: Monday - Friday, 8 AM - 6 PM EST
Quantity in commerce: 992 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, 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 number: 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-2009-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2009-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-13
Z-2010-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-13

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)