ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80
Lot Codes / Batch Numbers
Lots 262849 through 445216
Products Sold
Lots 262849 through 445216
A medical device manufacturer is recalling ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7 due to After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased proc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026