ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80
FDA Recall Z-0622-04 · Posted 2004-07-20
Recalling Firmev3, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-01-29
Date Terminated2005-11-08
Product Quantity446
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed nationwide in the United States and internationally to China and Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.