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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 179 units of the Habib EUS RFA device (20mm electrode active tip, Material Number 6700) distributed worldwide and across numerous U.S. states and countries including Canada, India, Australia, Great Britain, Greece, and Spain. The device is used for coagulation and ablation of soft tissue. The recall was initiated because testing revealed a temperature increase at the tip of the EUS-FNA needle when used with the device, caused by capacitive coupling that allows energy to transfer from the active tip to the introducer device. This unintended energy transfer could cause thermal injury to tissue outside the intended treatment area.
The affected product includes five batches with expiration dates ranging from July 2020 to February 2021. The record does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 179 Lot/code info: Material Number/UPN: 6700 GTIN: 5060271140596 Batches: 17-C01 (Expiration: 10-Jul-2020), 17-C03 (Expiration: 12-Nov-2020), 17-C04 (Expiration: 18-Feb-2021), 17-C05 (Expiration: 18-Feb-2021), 17-C09 (Expiration: 19-Feb-2021)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.