Recall Z-0118-2007 ยท DQY Catheter, Percutaneous
Enpath Medical, Inc.
Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
| Date | Nov 2, 2006 (initiated Jun 27, 2006) |
| Status | Terminated |
| Reason | Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber. |
| Root cause | Other |
| Action | Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation. |
| Quantity | 2494 Units |
| Distribution | CA, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043489 | ENPATH DEFLECTABLE CATHETER Enpath Medical Incorporated, May 19, 2005 |