—#37978

Product

Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.

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 0028 through 0527 and 0700 through 0874.

Why it was recalled

The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, Thailand and United Arab Emirates.

Timeline

Recall initiated: 2005-03-17
Posted by FDA: 2005-03-31
Terminated: 2005-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37978. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.