Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath
FDA device recall Z-0118-2007 · posted 2006-11-02 · Terminated
Recall details
- Recalling firm
- Enpath Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 2494 Units
- Distribution
- CA, MA
- Date initiated
- 2006-06-27
- Date posted
- 2006-11-02
- Date terminated
- 2007-04-14
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENPATH DEFLECTABLE CATHETER (K043489) | Enpath Medical Incorporated | 2005-05-19 |