Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minn
FDA device recall Z-1573-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Enpath Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 140
- Distribution
- MA
- Date initiated
- 2005-08-31
- Date posted
- 2005-09-21
- Date terminated
- 2006-07-22
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENPATH DEFLECTABLE CATHETER (K043489) | Enpath Medical Incorporated | 2005-05-19 |