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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 741–760 of 1,000 recalls

Class ITerminated

Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex Unit Dose 15 ml Normal Saline ¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Medline Prefilled 550 ml Sterile¿¿ ¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

September 5, 2017 · DeviceView details →

Class ITerminated

Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

St Jude Medical Inc.

The device may exhibit premature battery depletion.

August 28, 2017 · DeviceView details →

Class ITerminated

Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

St Jude Medical Inc.

The device may exhibit premature battery depletion.

August 28, 2017 · DeviceView details →

Class ITerminated

Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators

Leonhard Lang Medizintechnik GmbH

Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

August 8, 2017 · DeviceView details →

Class ITerminated

Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Spectranetics Corporation

Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

August 7, 2017 · DeviceView details →

Class ITerminated

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

OriGen Biomedical, Inc.

Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).

August 2, 2017 · DeviceView details →

Class ITerminated

Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.

Edwards Lifesciences, LLC

A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.

July 21, 2017 · DeviceView details →

Class ITerminated

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Philips North America, LLC

Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.

July 12, 2017 · DeviceView details →

Class ITerminated

CS 300 Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

June 16, 2017 · DeviceView details →

Class ITerminated

CS 100i Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

June 16, 2017 · DeviceView details →

Class ITerminated

CS 100 Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

June 16, 2017 · DeviceView details →

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