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Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Sterile barrier might be damaged compromising the sterility of the device.