ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
Lot Codes / Batch Numbers
Lot 1772812
Products Sold
Lot 1772812
A medical device manufacturer is recalling ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. due to Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Le. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
Recommended Action
Per FDA guidance
Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.
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
IL, PA
Page updated: Jan 10, 2026