Z-2481-2010

Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular...

Name: Z-2481-2010 Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2010-09-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-09-10 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed... on 2010-09-10. The reason FDA records is "The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly...". 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-2481-2010
Status: Terminated
Initiated: 2010-09-10
Posted: 2010-09-23
Terminated: 2011-12-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM 6 PM EST.
Quantity in commerce: 1315
Distribution: Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.
Product codes and lots: Serial numbers 0001-1315.

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)