Bard Peripheral Vascular Inc Opti-Plast Balloon Dilatation Catheters Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Opti-Plast Balloon Dilatation Catheters
Brand
Bard Peripheral Vascular Inc
Lot Codes / Batch Numbers
Models: XT75410, XT100410, XT120410
Products Sold
Models: XT75410, XT100410, XT120410
Bard Peripheral Vascular Inc is recalling Opti-Plast Balloon Dilatation Catheters due to Product intended for distribution outside USA was distributed without premarket notification requirements being met.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product intended for distribution outside USA was distributed without premarket notification requirements being met.
Recommended Action
Per FDA guidance
The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
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 noticeDistribution
As reported by FDA
AL, LA, MS, OH, VA
Page updated: Jan 10, 2026