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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 139 units of the Habib EUS RFA device with a 10mm electrode active tip (Material Number 6500) distributed worldwide, including in the United States, Canada, India, Australia, Great Britain, Greece, and Spain. During testing, the device was found to pose a risk of energy transfer from the active tip to the introducer needle through capacitive coupling, which could cause a temperature increase at the needle tip and potentially result in thermal injury to tissue outside the targeted treatment area.
The recalled device was distributed in four batches with expiration dates between July 2020 and February 2021. The source document does not specify what action 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: 139 Lot/code info: Material Number/UPN: 6500 GTIN: 5060271140725 Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-2021), 17-C07 (Expiration: 19-Feb-2021), 17-C08 (Expiration: 20-Feb-2021)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.