Recall Z-1315-04 ยท MCW Catheter, Peripheral, Atherectomy
Datascope Interventional Products Division
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
| Date | Aug 7, 2004 (initiated Jul 12, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031610 | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, May 27, 2003 |