Class I - Dangerous
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Class I - Dangerous
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Class I - Dangerous
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
The batteries have the potential to overheating, melt or char.
The batteries have the potential to overheating, melt or char.
Class I - Dangerous
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Potential coating contamination with glass particles.
Class I - Dangerous
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Class I - Dangerous
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Class I - Dangerous
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
The batteries have the potential to overheating, melt or char.
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Novus Scientific Ab
Class I - Dangerous
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.
Class I - Dangerous
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier