Boston Scientific Corporation - Malecot Nephrostomy Catheter Set, - Class 2 Recall
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Percutaneous Access Set - Class 2 Recall
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - ReEntry Malecot Nephrostomy Catheter Set - Class 2 Recall
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2018 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - BIO CAL(R) 370/370I Temperature Controller - Class 2 Recall
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2018 Category: Medical Devices Source Type: alerts

LivaNova USA - Sorin Group Smart Perfusion Pack EPack - Class 3 Recall
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2018 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium B - Class 2 Recall
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 ...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 - Class 2 Recall
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration. (Source: ...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - Tubing Pack - Class 2 Recall
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 31, 2018 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 100 IntraAortic Balloon Pump - Class 1 Recall
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 100i IntraAortic Balloon Pump - Class 1 Recall
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 300 IntraAortic Balloon Pump - Class 1 Recall
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Sorin Group USA, Inc. - Cardiopulmonary Bypass Catheter Cannula and Tubing - Class 2 Recall
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2017 Category: Medical Devices Source Type: alerts

Sorin Group USA, Inc. - SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts

Sorin Group USA, Inc. - SMART PERFUSION PACK - Class 2 Recall
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts

Sorin Group USA, Inc. - SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK - Class 2 Recall
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts