Z-0281-2013Class II

Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is...

Name: Z-0281-2013 Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-25 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the... on 2012-09-25. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be...". 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-0281-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-25
Posted: 2012-11-13
Terminated: 2013-07-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 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 multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described 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 to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com. If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
Quantity in commerce: 1097
Distribution: Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
Product codes and lots: catalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0280-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0281-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0282-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0283-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0284-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0285-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13

Product code DTQ

K915183Class IISarns 8000 Modular Perfusion System3M Health Care, Sarns / cleared 1992-07-08

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)