Z-0436-2013Class II

220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for...

Name: Z-0436-2013 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-11-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-11-14 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal... on 2012-11-14. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no...". 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-0436-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2012-11-27
Terminated: 2013-08-30
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 220/240V AC, Advanced Perfusion System Platform (APS) 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 System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Cardiovascular Systems sent a Urgent Medical Device Recall Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Terumo CVS is alerting all users of Terumo System 1 of the reports of malfunction. Customers were instructed to: 1. Review this Medical Device Safety Advisory. 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. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818, Recall Fax 1-734-741-6149 Customer Service Hours: Monday thru Friday, 8 AM - 6 PM ET
Quantity in commerce: 1647 units total
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, 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.
Product codes and lots: Catalog number: 801764 and all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0436-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0435-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27
Z-0436-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

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)