Terumo Cardiovascular Systems Corp - Cardiovascular Procedure Kit - Class 2 Recall
Cardiovascular Procedure Kit catalog # 76645 & 73806 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2022 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular, LLC - Ultima Activator II Reusable Drive Mechanism - Class 2 Recall
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2022 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular, LLC - Interavascular SAS/Getinge - Class 2 Recall
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2022 Category: Medical Devices Source Type: alerts
Philips North America Llc - Class 2 Recall
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2021 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - WIRION EMBOLIC PROTECTION SYSTEM - Class 1 Recall
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2021 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular, LLC - Hemashield Gold Knitted Bifurcated - Class 2 Recall
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Philips Allura Xper FD20/20 - Class 2 Recall
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis." "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies ...
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Philips Allura Xper FD20 - Class 2 Recall
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies ...
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Philips Azurion 7 M20 - Class 2 Recall
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM - Class 2 Recall
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2021 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM - Class 2 Recall
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2021 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2021 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo HX2 Temperature Management System - Class 2 Recall
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for ...
Source: Medical Device Recalls - June 5, 2021 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns TCM - Class 2 Recall
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2021 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns TCM II - Class 2 Recall
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia...
Source: Medical Device Recalls - June 5, 2021 Category: Medical Devices Source Type: alerts
