Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System
FDA device recall Z-0946-2009 · posted 2009-01-30 · Terminated
Recall details
- Recalling firm
- St. Jude Medical Inc
- Reason for recall
- Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
- Action taken
- The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.
- Root cause
- Other
- Status
- Terminated
- Product code
- OCL
- Quantity affected
- 158 units distributed.
- Distribution
- Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.
- Date initiated
- 2008-12-09
- Date posted
- 2009-01-30
- Date terminated
- 2010-12-28
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPICOR ABLATION SYSTEM (K080292) | St Jude Medical | 2008-07-25 |