Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520
FDA Recall Z-1107-03 · Posted 2003-08-12
Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeGBR
Date Initiated2003-07-01
Date Terminated2006-12-28
Product Quantity12
Reason for Recall
Some of the product pouches have holes in the seals.
Firm Action
Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Root Cause
Other
Distribution Pattern
The recalled products were shipped to hospitals located nationwide in the United States.
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.