—#53816

Product

Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

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 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176.

Why it was recalled

Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.

Root cause (FDA determination)

Component change control

Action the firm took

Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-09-10
Posted by FDA: 2007-12-01
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.