Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product

• Product Names: Single Use Guide Sheath Kits:
  • K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush
  • K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps
  • K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush
  • K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps
• Unique Device Identifier (UDI)/Model:
  • 04953170245466/K-201
  • 04953170245480/K-202
  • 04953170245503/K-203
  • 04953170245527/K-204
• Lot Numbers: All lots   

What to Do  

• Do not use Single Use Guide Sheath Kits with model numbers models K-201, K-202, K-203 or K-204. 

On January 15, 2025, Olympus sent all affected customers an Urgent Medical Device Removal letter recommending the following actions:

• Identify Single Use Guide Sheath Kits, models K-201, K-202, K-203, and K-204 in inventory.
• Do not use Single Use Guide Sheath Kits with these model numbers.
• Quarantine any affected product. 
• Contact Customer Service at 1-800-848-9024, option 2, if affected products are found in inventory, to receive a Return Material Authorization. Olympus will issue a credit upon return of affected product.
• Acknowledge receipt of the letter through the Olympus web portal.
  • Enter the recall number "0467”
  • Complete the form as instructed.
• Forward the notice to other users who may have received affected products.

Reason for Recall  

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 use of affected product may cause serious adverse health consequences, including bleeding and death.  
 
There have been 26 serious reported injuries. There have been no reports of death. 

Device Use

Single Use Guide Sheath Kits models K-201, K-202, K-203, and K-204 contain Single Use Guide Sheaths models SG-200C and SG-201C. These instruments are designed for use with an Olympus endoscope to collect cells or tissue specimens in the organs responsible for breathing. 

Contact Information  

Customers in the U.S. with questions about this recall should contact Olympus Technical Assistance Center (TAC) at 1- 800-848-9024, option 1.

Additional FDA Resources  

• FDA’s Enforcement Report
• Medical Device Recall Database

Additional Company Resources  

• Firm Recall Web Portal

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label? 
• AccessGUDID database - Identify Your Medical Device 
• Benefits of a UDI System  

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.