Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
SPS Sterilization
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
The set screw is not able to advance or reverse from the original position in the nail.
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Micro Therapeutics Inc
The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
SPS Sterilization
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver