Recall archive
20 recalls · page 1 of 1
Reported Feb 28, 2018
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LivaNova USA
Matched: Brand · Product · Product details — The product is labeled with the incorrect expiration date.
FDA (openFDA device enforcement)
Reported Nov 15, 2017
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand — A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
FDA (openFDA device enforcement)
Reported Aug 16, 2017
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details — Identification of excess plastic on the tip of the cannula.
FDA (openFDA device enforcement)
Reported Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details — Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 230 V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand — Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the…
FDA (openFDA device enforcement)
Reported Dec 7, 2016
ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to…
FDA (openFDA device enforcement)
Reported Nov 23, 2016
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2016
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2016
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Sorin Group USA, Inc.
Matched: Brand · Product · Product details — The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the…
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the…
FDA (openFDA device enforcement)
Reported Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand — Isoline defibrillation leads distributed may have internal insulation breach.
FDA (openFDA device enforcement)
Reported Nov 14, 2012
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 7, 2012
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Reason for recall — Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2012
Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Brand · Product details — Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and…
1 more product in this recall
FDA (openFDA device enforcement)
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