Recall archive
61 recalls · page 3 of 3
Reported Oct 31, 2012
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2012
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured…
FDA (openFDA device enforcement)
Reported Oct 17, 2012
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2012
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2012
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2012
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and…
FDA (openFDA device enforcement)
Reported Aug 15, 2012
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 1, 2012
System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2012
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2012
Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality.…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2012
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2012
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the…
10 more products in this recall
FDA (openFDA device enforcement)
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