—#49812

Product

Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 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 0030 through 0998 may be affected. Serial numbers 0052, 0418, 0559, 0745 and 0767 have been corrected.

Why it was recalled

The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.

Root cause (FDA determination)

Other

Action the firm took

The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2004-09-01
Posted by FDA: 2007-06-30
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49812. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.