—#53814

Product

Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, 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 2110 through 2125.

Why it was recalled

Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong and United Arab Emirates.

Timeline

Recall initiated: 2007-09-10
Posted by FDA: 2007-12-01
Terminated: 2008-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53814. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.