Z-0882-2011

Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble...

Name: Z-0882-2011 Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2010-12-02
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-12-02 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect... on 2010-12-02. The reason FDA records is "The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion...". 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-0882-2011
Status: Terminated
Initiated: 2010-12-02
Posted: 2011-01-07
Terminated: 2012-04-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. The firm identified a fai
Root cause tag: design
FDA root cause: Component design/selection
Action: Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule. Customers were to review the Medical Device Correction. Assure that all user were aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call 1-800-521-2818.
Quantity in commerce: 508 devices
Distribution: Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
Product codes and lots: 01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01564, 01565-01581, 01583-01609, 01611, 01613-01660, 01662-01721, 01724-01725.

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)