Z-0626-2011

ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm...

Name: Z-0626-2011 ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm...
Creator: Ev3, Inc.
Published: 2010-10-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-10-30 / Terminated / root cause: packaging

FDA source

Ev3, Inc. began a recall of ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc... on 2010-10-30. The reason FDA records is "Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0626-2011
Status: Terminated
Initiated: 2010-10-30
Posted: 2010-12-16
Terminated: 2012-03-29
Recalling firm: Medtronic, Inc.
Product: ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Protg GPS stent but actually contai
Root cause tag: packaging
FDA root cause: Packaging process control
Action: ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.
Quantity in commerce: 30
Distribution: Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
Product codes and lots: Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).

Product code FGE

K050725Class IIProtege Gps Self-Expanding Nitinol StentEv3 Corporation / cleared 2005-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)