Z-1969-2012Class II

System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the...

Name: Z-1969-2012 System 1 Base 220/240V 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: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of System 1 Base 220/240V 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 occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment...". 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-1969-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-25
Posted: 2012-07-09
Terminated: 2015-09-18
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: System 1 Base 220/240V 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 occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" notification dated June 25, 2012 and an update to the Operator's Manual for the Terumo Advanced Perfusion System 1 via Federal Express to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review this Medical Device Recall notice; assure that all users are aware of this notice; place the addendum at the beginning of the Roller Pumps Section (page 5.1) of the Operator's Manual, and complete and return the attached Customer Response Form to the fax number/email address indicated on the form. Note: Terumo is continuing its investigation into the root cause of the malfunctions, and may initiate further action pending results of the investigation. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours: Monday-Friday, 8 AM - 6 PM (ET).
Quantity in commerce: 648 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Germany, 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: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and1441.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1969-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1968-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1969-2012	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)