Recall Z-0916-03 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp
10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Ballo
| Date | Jun 5, 2003 (initiated Mar 21, 2003) |
| Status | Terminated |
| Reason | 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection. |
| Root cause | Other |
| Action | Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003. |
| Quantity | 60 units |
| Distribution | Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964987 | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 Datascope Corp., Mar 17, 1997 |