FDA Device

ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

Hazard

The motor may fail to activate when the on/off switch is pressed.

What You Should Do

Remedy

Letter dated July 16, 2004 was mailed via US mail, return receipt requested.

Products

ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Brand
Datascope Interventional Products Division
UPC
Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08; M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.

Units Affected

892