Z-2018-2014Class II

Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

Name: Z-2018-2014 Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-06-17
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-06-17 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) on 2014-06-17. FDA classified it as Class II and gives the reason as "An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2018-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-17
Posted: 2014-07-08
Terminated: 2014-09-22
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On June 17, 2014, TCVS sent URGENT MEDICAL DEVICE RECALL notification to consignees. Notification included reason for recall, potential hazard, correction, affected population, and customer instructions. Questions concerning the recall are directed to Terumo CVS Customer Service @ 800-521-2818 (M-F, 8am-6pm)
Quantity in commerce: 1713 units
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, 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 AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
Product codes and lots: Catalog Number 801763

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2018-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2018-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-08
Z-2019-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-08

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)