Z-0310-2009

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced...

Name: Z-0310-2009 Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-07-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-07-18 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal... on 2008-07-18. The reason FDA records is "The pumps may fail to power up or experience unplanned pump stops". 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-0310-2009
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-11-25
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The pumps may fail to power up or experience unplanned pump stops.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.
Quantity in commerce: 1429
Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.
Product codes and lots: Serial numbers 0030, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594.

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)