Datascope Interventional Products Division ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Brand
Datascope Interventional Products Division
Lot Codes / Batch Numbers
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.
Products Sold
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.
Datascope Interventional Products Division is recalling ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shel due to The motor may fail to activate when the on/off switch is pressed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The motor may fail to activate when the on/off switch is pressed.
Recommended Action
Per FDA guidance
Letter dated July 16, 2004 was mailed via US mail, return receipt requested.
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