Z-0301-2012

Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1

Name: Z-0301-2012 Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-11-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-11-10 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6... on 2011-11-10. The reason FDA records is "Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the...". 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-0301-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2011-11-29
Terminated: 2012-09-06
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: 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 CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
Product codes and lots: Catalog number 801041 (Serial Numbers 0216, 0233, 0354, 0800,and 2588)

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)