Recall Z-0973-2011
Boston Scientific Corp · initiated July 14, 2009
Product
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.
Codes / lots: Serial numbers 49615 56781 57259 59544 61161 62244 62643 62694 62881 63271 49889 56794 57260 59545 61162 62245 62644 62695 62882 63272 49895 56800 57261 59549 61163 62246 62645 62696 62883 63273 50100 56801 57263 59550 61164 62247 62646 62698 62884 63274 50108 56805 57267 59552 61165 62248 62647 62699 62885 63275 50531 56806 57613 59555 61166 62249 62648 62844 62886 63276 50807 56810 58739 59560 61167 62250 62649 62845 62887 63277 51710 56812 58742 59564 61168 62251 62650 62846 62888 63278 52362 56814 58743 59565 61170 62253 62651 62847 62889 63279 52363 56815 58745 59567 61171 62255 62653 62848 62890 63280 52364 56816 58746 59568 61173 62256 62654 62849 62891 63281 52365 56817 59156 59569 61870 62257 62655 62850 62892 63282 52369 57190 59186 59819 61871 62258 62657 62851 62893 63283 52370 57193 59187 61116 61873 62259 62658 62852 62894 63284 52371 57194 59189 61117 61875 62260 62659 62853 62895 63285 52377 57199 59190 61118 61876 62262 62660 62854 62896 63286 52394 57200 59191 61119 61880 62265 62663 62855 62897 63287 52395 57201 59192 61120 61881 62266 62665 62856 62898 63288 52397 57203 59193 61122 61882 62267 62666 62857 62899 63289 53543 57209 59194 61123 61885 62268 62667…
Reason for recall
Product malfunction causes inadvertent delivery of energy.
FDA-determined cause: Nonconforming Material/Component
Action taken
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: wareb@bsci.com.
Details
- Recall number
- Z-0973-2011
- Initiated
- July 14, 2009
- Posted by FDA
- January 27, 2011
- Terminated
- January 27, 2011
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 1044 units
- Distribution
- Worldwide distribution
- Recalling firm
- Boston Scientific Corp, San Jose, CA