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.
FDA Recall Z-0973-2011 · Posted 2011-01-27
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeLPB
Date Initiated2009-07-14
Date Terminated2011-01-27
Product Quantity1044 units
Reason for Recall
Product malfunction causes inadvertent delivery of energy.
Firm 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 Corporation sales representatives will contact each customer.
If you have any questions, please contact 408-935-4952 or email: [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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