—#43931

Product

Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial numbers 0033 through 1263.

Why it was recalled

The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.

Root cause (FDA determination)

Other

Action the firm took

The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide-USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Timeline

Recall initiated: 2006-06-30
Posted by FDA: 2006-08-22
Terminated: 2008-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.