Recall Z-0668-2020 ยท JOS Electrode, Electrosurgical
Boston Scientific Corporation
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention. |
| Root cause | Device Design |
| Action | On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Recall - Immediate Action Required HABIB" EUS RFA 6500 and 6700 Dear Materials Manager / Field Action Contact: Boston Scientific (BSC) is initiating a voluntary removal of all HABIB" EUS RFA devices that remain in distribution. BSC acquired EMcision in March 2018. EMcision was the manufacturer of the Habib EUS RFA devices subject to this recall. The EMcision UK entity is no longer operating, therefore BSC is initiating the action. BSC recently identified that the |
| Quantity | 179 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161305 | Habib EUS RFA Emcision , Ltd., Jul 7, 2016 |