Recall Z-0973-2011 ยท LPB Cardiac Ablation Percutaneous Catheter
Boston Scientific Corp
RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000xp Cardiac Ablation Controllers and Foot Switch are indicated for use in cardiac ablation procedures with standard and high power BSC cardiac ablation Catheters.
| Date | Jan 27, 2011 (initiated Jul 14, 2009) |
| Status | Terminated |
| Reason | Product malfunction causes inadvertent delivery of energy. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Boston Scientific, sent an "URGENT: Medical Device Recall" letter dated January 14, 2009, with attached recall instructions to all customers. The letter described the product, problem, and the action to be taken by the customers. The customers were instructed to complete and return the Reply Verification Tracking Form and Obtain an RGA via fax to 408-957-6204; and return the recalled product using BSC Federal Express Number 1-809-4713-2 via second day delivery to Boston Scientific Corporation, Distribution Center, 500 Commander Shea Blvd., Quincy, MA 02171. Boston Scientific Corp |
| Quantity | 1044 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.