Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015
Lot Codes / Batch Numbers
Lot numbers 5490976, 5530109, and 5564475
Products Sold
Lot numbers 5490976, 5530109, and 5564475
A medical device manufacturer is recalling Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon l due to Some of the product pouches have holes in the seals.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the product pouches have holes in the seals.
Recommended Action
Per FDA guidance
Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
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