Z-1315-04

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

Name: Z-1315-04 ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton
Creator: Datascope Interventional Products Division
Published: 2004-07-12
License: https://open.fda.gov/license/

Datascope Collagen Products Division / initiated 2004-07-12 / Terminated

FDA source

Datascope Interventional Products Division began a recall of ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton on 2004-07-12. The reason FDA records is "The motor may fail to activate when the on/off switch is pressed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1315-04
Status: Terminated
Initiated: 2004-07-12
Posted: 2004-08-07
Terminated: 2004-11-22
Recalling firm: Datascope Collagen Products Division
Product: ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: The motor may fail to activate when the on/off switch is pressed.
FDA root cause: Other
Action: Letter dated July 16, 2004 was mailed via US mail, return receipt requested.
Quantity in commerce: 892
Distribution: The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
Product codes and lots: 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.

Product code MCW

K031610Class IIRex Medical Cleaner Rotational Thrombectomy SystemRex Medical / cleared 2003-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)