Recall Z-1573-05 ยท DYB Introducer, Catheter
Enpath Medical, Inc.
Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to defl
| Date | Sep 21, 2005 (initiated Aug 31, 2005) |
| Status | Terminated |
| Reason | Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole. |
| Root cause | Other |
| Action | Clinical locations were sent an Urgent Medical Device Recall letter dated 09/02/05 from Enpath Medical, Inc. The letter states the issue, affected lots to be segregated and to discontinue use of. A Bard Electrophysiology Territory Manager will retrieve affected product. |
| Quantity | 140 |
| Distribution | MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043489 | ENPATH DEFLECTABLE CATHETER Enpath Medical Incorporated, May 19, 2005 |