Z-0613-04

ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014"...

Name: Z-0613-04 ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014"...
Creator: ev3, Inc.
Published: 2004-01-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-01-29 / Terminated

FDA source

ev3, Inc. began a recall of ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80 on 2004-01-29. The reason FDA records is "After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0613-04
Status: Terminated
Initiated: 2004-01-29
Posted: 2004-07-20
Terminated: 2005-11-08
Recalling firm: Medtronic, Inc.
Product: ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
FDA root cause: Other
Action: A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.
Quantity in commerce: 446
Distribution: The product was distributed nationwide in the United States and internationally to China and Ireland.
Product codes and lots: Lots 262849 through 445216

Product code FGE

K033134Class IIModification to Paramount Mini Stent and Delivery SystemEv3, Inc. / cleared 2003-11-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)