Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
Lot Codes / Batch Numbers
Lot # 672655
Products Sold
Lot # 672655
A medical device manufacturer is recalling Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary) due to Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').
Recommended Action
Per FDA guidance
Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026