Recall Z-1970-2012— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1970-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-25

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-06-25, terminated 2013-03-01. It names one FDA 510(k) clearance: K022947. Product: System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu.

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-06-25
Terminated: 2013-03-01
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K022947 — ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp.·cleared 2003-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu

Data sourced from openFDA. This site is unofficial and independent of the FDA.