—#67165

Product

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.

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, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594.

Why it was recalled

The pumps may fail to power up or experience unplanned pump stops.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.

Timeline

Recall initiated: 2008-07-18
Posted by FDA: 2008-11-25
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.