FDA Medical Device Recalls (openFDA)
Datascope Interventional Products Division: ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
- Recall number
- Z-1315-04
- Recalling firm
- Datascope Interventional Products Division
- Product
- ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
- Status
- Terminated
- Initiated
- 2004-07-12
- Posted
- 2004-08-07
- Terminated
- 2004-11-22
- Reason
- The motor may fail to activate when the on/off switch is pressed.
- Root cause
- Other
- Action
- Letter dated July 16, 2004 was mailed via US mail, return receipt requested.
- Quantity
- 892
- Distribution
- The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K031610"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3003071194
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28