|
Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
Olympus is recalling certain models of Single Use Guide Sheath Kits after receiving complaints that the radiopaque tip of the guide sheath component fell off into the patient. Olympus’s preliminary findings show that the tip detaches from the guide sheath when excessive force is applied as instruments are inserted into the guide sheath, and/or if there is damage to the distal end of the sheath.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Olympus Technical Assistance Center (TAC) at 1- 800-848-9024, option 1.
|
