Recall archive
61 recalls · page 2 of 3
Reported Oct 12, 2016
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error…
FDA (openFDA device enforcement)
Reported Jul 27, 2016
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two…
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) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2016
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL…
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 — Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which…
FDA (openFDA device enforcement)
Reported Sep 16, 2015
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
FDA (openFDA device enforcement)
Reported Jun 3, 2015
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use 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 is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2015
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly…
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 — Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix…
FDA (openFDA device enforcement)
Reported Jul 30, 2014
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2014
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand — During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 28, 2014
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral…
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Sterility of medical devices intended for use in surgical procedures may be compromised.
FDA (openFDA device enforcement)
Reported Jan 8, 2014
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as…
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 — Medical device used in cardiovascular procedures is defective.
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1…
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 — The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists.…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2013
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation…
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 discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2013
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
FDA (openFDA device enforcement)
Reported Feb 20, 2013
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation…
FDA (openFDA device enforcement)
Reported Jan 23, 2013
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand — Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2012
24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand — The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2012
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use 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 Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2012
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system 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 — Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified…
7 more products in this recall
FDA (openFDA device enforcement)
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