FDA Device

Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011

Hazard

Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain.

What You Should Do

Remedy

Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them.

Products

Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
Brand
Boston Scientific Scimed
UPC
Lot Number 400934

Units Affected

11 catheters