—#96152

Product

Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. 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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 00632-00635, 00638, 00642-00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2010-12-02
Posted by FDA: 2011-01-07
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.