Recall Z-0667-2020— Boston Scientific Corporation

Name: FDA recall Z-0667-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-18

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-11-18, terminated 2020-06-25. It names one FDA 510(k) clearance: K161305. Product: Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Terminated: 2020-06-25
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K161305 — Habib EUS RFAEmcision , Ltd.·cleared 2016-07-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.