Z-2046-2012Class II

Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is...

Name: Z-2046-2012 Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-18 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal... on 2012-06-18. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various...". 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-2046-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Posted: 2012-07-19
Terminated: 2013-04-12
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. 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 has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to complete and return a Customer Response Form via fax to 1-800-292-6551. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
Quantity in commerce: 461 untis
Distribution: Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.
Product codes and lots: Catalog Number 16405 and serial number 1001-1461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2043-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2044-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2045-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2046-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2047-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2048-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2049-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2050-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2051-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19
Z-2052-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

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)