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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 281–300 of 1,000 recalls

Class ITerminated

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Abbott Vascular

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

January 29, 2020 · DeviceView details →

Class ITerminated

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

CME America, LLC

Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)

January 7, 2020 · DeviceView details →

Class ITerminated

HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

TELEFLEX MEDICAL INC

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

December 13, 2019 · DeviceView details →

Class ITerminated

HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

TELEFLEX MEDICAL INC

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

December 13, 2019 · DeviceView details →

Class ITerminated

HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit

TELEFLEX MEDICAL INC

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

December 13, 2019 · DeviceView details →

Class ITerminated

HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit

TELEFLEX MEDICAL INC

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

December 13, 2019 · DeviceView details →

Class ITerminated

0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO

Argon Medical Devices, Inc

The stiffness of the soft end of the guidewire caused tissue perforation.

December 4, 2019 · DeviceView details →

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