510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2169-2008

Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth...

Medtronic, Inc. / initiated 2008-04-22 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Ev3, Inc began a recall of Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311... on . The reason FDA records is "A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2169-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree.
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall
A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
Quantity in commerce
1
Distribution
Nationwide Distribution --- state of LA.
Product codes and lots
Lot 2675311