ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
Lot Codes / Batch Numbers
Lot 117182
Products Sold
Lot 117182
A medical device manufacturer is recalling ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. S due to A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affec. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
Recommended Action
Per FDA guidance
ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.
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
FL, PA
Page updated: Jan 10, 2026